Flexitouch Pd32-u Lymphedema Treatment System Pump. Yes, taking care of ones body requires several interventions. >> The Flexitouch system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs 2008-2023 HMP Global, Inc. All rights reserved. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Flexitouch Plus provides flexible program options. I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. /W 0 /CS /DeviceRGB /MediaBox [0.0 0.0 612.0 792.0] /CropBox [0.0 0.0 612.0 792.0] Subject overall health and quality of life in the past week-EORTC C30. Learn More Take the steps now to help your head and neck cancer survivors. /Length 680 Michelin Man came to mind as I stretched out on the couch. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /TT1 70 0 R Listing a study does not mean it has been evaluated by the U.S. Federal Government. Chronic Wounds endobj The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Tactile Systems Technology, Inc. I have been suffering from lymphedema for the past 2 years. EJVES. Negative value shows a decrease in swelling. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). /Annots [10 0 R 11 0 R 12 0 R] /S /Transparency Its brand new, used 1 time. /CropBox [0.0 0.0 612.0 792.0] Ideas? When I called my surgeon, he recommended that I not use the FlexiTouch on my chest because the compression can make the tissue expander rupture. 1. 6 0 obj Hi Deborah, How wonderful you have had such positive success with your pump. /S /Transparency Required fields are marked *. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. /Parent 2 0 R Except for my wrist, all my measurements showed reduction. 17 0 obj 2016;14(4):198205. I am looking for a left arm garment for the flexitouch plus. Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. >> Negative value shows a increase in quality of life. Upper set (head and neck). If you still have the system, I am interested. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. << I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. I wonder if pumps can be reprogrammed. /StructParents 7 Hi Kristie, Thank you for sharing your story. I just received the flexitouch plus, but I think the leg garments are too big. 35 0 R] }3eIH]^p~>_ y#h`*#OPQB_lVI"p! << Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Hi Wally, Hope someone is able to meet your request. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. by Flexitouch. 4 0 obj JAMA Dermatol. Im a pianist and its become my safe place. I was told purchased high priced left garments which I dont think I needed. /Tabs /S Oral Oncology. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Sign up today for your free Reader Account. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /Count 7 How customer reviews and ratings work See All Buying Options. Top reviews. /Parent 2 0 R /TT0 22 0 R 1(1): 114125. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. My interest in pumps suddenly skyrocketed! /C2_0 21 0 R A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. Ive heard from many people that they saw good results with their pump. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Deng J, et al. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) What really gripes me is that my nurse practitioner wouldnt even consider ordering one. I would suggest you keep contacting Tactile Medical. I use it everyday for an hour. They are programed for each individual. /Group << No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /Im0 24 0 R I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. Just wondering if you have any ideas of whom to contact on such a thing. /Type /Page I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. Thanks. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. /TT0 69 0 R As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. stream In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. It seems a lot of pumps are preprogrammed for the individual. % Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 13 0 obj All reviewers. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. The Flexitouch System is not used for nor intended for use to treat cellulitis. /Resources << For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Resources << >> The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. D/N500187-000-00 Rev. My husband?s pump system arrived yesterday. I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. You are benefiting the lymphedema community. Actually they dont know much about lymphedema. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). I dont like that I have to do it but it has changed my legs back to normal. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN /Type /Pages My insurance company required me to use a different brand of compression pump and experience failure before they would consider covering the cost of a Flexitouch. >> Another set of pads enveloped my left thigh and trunk. /F 4 But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /ProcSet [/PDF /Text /ImageC] It takes just 32 minutes per day. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. It takes just 32 minutes per day. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. endstream Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. & weigh 126 lbs. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. >> https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. << endobj << 3701 Wayzata Blvd, Suite 300 >> /A << Explain the situation to them. stream >> Hi Wandalynn . /MediaBox [0 0 612 792] I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. 5. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Last updated March 2021. /Subtype /Link /TT3 74 0 R /TT0 23 0 R The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /ProcSet [/PDF /Text] 2. I like to joke, Honey, time for me to put the squeeze on you The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. Minneapolis, MN 55416 USA They use them in the morning, at nightand feel very lucky.. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) It was up to me to piece it together. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /Im0 60 0 R Please remove one or more studies before adding more. endobj Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /CS /DeviceRGB Lymphat Res Biol, 2016. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /Type /Page If anyone has one, or knows of one, please contact me. /Type /Group 1. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. Positive value shows an increase in Function/Range of Motion. Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). /Filter /FlateDecode Buying a reconditioned machine saved me some money. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 2. https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. stream I can relate all too well to what you have been through. The woman from Idaho said her arm was softer and found the machine easy to use. ? My thighs are so big that I can no longer Drive. endobj XJ /Contents [13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 0 R] Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Keep in touch! Information provided by (Responsible Party): The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. Support Care Cancer (2020). /Type /Page << I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. /Tabs /S I only make 12k per year so its not like I can afford anything. << Managing my lymphedema requires attention and an assortment of tools. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. 11 0 obj The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. For general information, Learn About Clinical Studies. . I cant explain that but I can visually see a difference. /TT1 70 0 R Phone: 1.612.355.5100 /TT2 51 0 R Free shipping for many products! Breast cancer and treatment in itself was an awful journey. /Font << /StructParents 8 HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Minneapolis, MN 55416 USA | Source: I was rather startled at how wrapped up I was. >> My therapist said they cannot be reused by another. Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. S If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? /Subtype /Link Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. It has become so bad that I can barely walk. Filter by. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. << Ive had my Flexitouch for almost five months. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Group << In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. 7 0 obj I have lymphedema in my right arm, breast and axilla. 1 0 obj To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /StructParents 0 Surprisingly, my therapists measurements showed minimal difference with previous measurements. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. My best to you. * American Society of Clinical Oncology 1. /BS << /Type /Group /Length 450 /Contents 73 0 R phone: +1 (623) 738-9011 (57) Webstore 3. /Length 412 << >> Since using the Flexitouch for almost a year, she had not experienced cellulitis. << I have little confidence that the FaceTime call offered will be of much use. I have skipped 1 or 2 days just 3 or 4 times since March. /Rotate 0 The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. Numerous clinical studies show achievement of major clinical benefits and cost savings I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. >> I dont know if it will make a difference. I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. /CropBox [0 0 612 792] https://doi.org/10.1007/s00520-020-05540-8, 3. I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. (Therapists couldnt afford themselves to take insurance payments because most insurances do not reinburse them enough to make it worthwhile) All in all I finally found the Lymphedema Center (why dont doctors know this) and took some classes and found an amazing therapist who has helped and has been trained in lymphedema and a few massage therapists that know what they are doing and are trained. Hi Jaime, Im hopeful that your new pump will provide relief. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Minneapolis, MN 55416 USA Positive value shows an increase in quality of life/overall health. Ive always been diligent about caring for my lymphedema but if there was a product that could further the health of my left arm, I was going to investigate. I always start with the one hour full arm and core setting. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. I wanted to talk to some people who had actually used the pump. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. /W 0 Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions. They are in contact with patients who could benefit from a pneumatic pump. /CropBox [0 0 612 792] Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. K-ZB: When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. Venous Ulcers. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] I know many others can as well. Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. PW!\v(jfz:yX 8$W"wqHbxQDL >> << /MediaBox [0.0 0.0 612.0 792.0] /TT2 74 0 R Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time /URI (http://www.fda.gov/) Positive value shows an decrease in quality of life. It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) I would be interested to hear how your husbands experience with his new pump. Im sorry for the experience you had with Tactile Medical. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Keep sharing your story. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. /Type /Page I had a mastectomy and 9 lymph nodes removed 3 months ago. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Two years on pump controller and garments. 2016;14(4):198205. /Resources << In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] I did a baseline measurement of my left arm before treatment and three weeks after using the pump. I just received it yesterday and Im super hopeful that it will help. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. << Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) Hi Karyn, I will post your comment and see if Sarah still has the pump available. For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. /XObject << Phone: 1.612.355.5100 The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system.