>> Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. /Rotate 0 /S /Transparency HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. I have it in both of my legs mostly in my thighs. /CropBox [0.0 0.0 612.0 792.0] 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 Percentage of each response captured. 14(4): p. 198-205, 2. Positive value shows an increase in symptoms/problems. Another set of pads enveloped my left thigh and trunk. Breast cancer and treatment in itself was an awful journey. /Type /Page where is the compassion for ill people that NEED certain healthcare to get better? 2. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R between head and neck cancer and lymphedema. I use it everyday for an hour. << 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. Numerous garment and program options to meet each patient's unique treatment needs 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. /C2_0 38 0 R To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. I still need to wear night garments and flat knit garmets and compression bras and self MLD but I feel like a weight has been lifted literally and physically. Listing a study does not mean it has been evaluated by the U.S. Federal Government. << /StructParents 6 /TT3 52 0 R I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. My go to place when I need calming. 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. It has made my life miserable. Its brand new, used 1 time. I have little confidence that the FaceTime call offered will be of much use. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. I am looking for a left arm garment for the flexitouch plus. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. endstream I wanted to talk to some people who had actually used the pump. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. He just never could get use to using it and being able to don the garments. Minneapolis, MN 55416 USA & weigh 126 lbs. /Parent 2 0 R The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Many, many of my patients love their pump. >> Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. /MediaBox [0.0 0.0 612.0 792.0] /MediaBox [0.0 0.0 612.0 792.0] /Type /Group did you sell it yet? View this study on Beta.ClinicalTrials.gov, 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 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. I need help but theres a no return policy. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Support Care Cancer (, 2020). All stars. Positive value shows an increase in Function/Range of Motion. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. For general information, Learn About Clinical Studies. /BS << /Type /Page /MediaBox [0 0 612 792] Two years on pump controller and garments. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Thank you for sharing your husbands success with a pump. 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. The pump is called the Flexitouch System by Tactile Medical. Pain will be assessed using the VAS Pain Scale. Explain the situation to them. /Tabs /S /Rotate 0 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. I didnt make a decision to purchase a pump that day. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. Hi Deborah, How wonderful you have had such positive success with your pump. /Filter /FlateDecode Listing a study does not mean it has been evaluated by the U.S. Federal Government. It has become so bad that I can barely walk. The pump has helped you achieve significant results. /S /Transparency Oral Oncology. Rockson floated to my ears. I have one new for sale. 46(4): 480487. It was up to me to piece it together. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. /Contents 75 0 R endstream I wish you success! does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? /Type /Page /Resources << I have been having weekly physical therapy to help with lymphedema and range of motion issues. Has anyone else had any experience with this? In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. 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. Hope it works out. /Length 470 >> document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. 1. 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. Subject Quality of Life will be assessed using EORTC C30 questionnaire. For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. Swelling will be assessed using the ALOHA measurement protocol. With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 12 0 obj The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 35 0 R] Write a review. Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. /TT0 69 0 R /StructParents 7 Tens of thousands of. Please remove one or more studies before adding more. 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, 3701 Wayzata Blvd, Suite 300 I just received the flexitouch plus, but I think the leg garments are too big. Negative value shows a decrease in symptoms/problems. Rz:MzI6 Overview Product Features Details Benefits >> /CS /DeviceRGB A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Font << Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? The lymphedema seen in patients treated for head . If you still have the system, I am interested. 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/. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 15 0 obj >> Required fields are marked *. I have a pump system left and right leg also stomach wraps. It delivers a noninvasive therapy that patients can administer 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. So for almost every night for the next seven years I sat down and performed MLD on my left arm. Text, image, video. /Resources << Dr. Shelia Ridner Dr. Barbara Murphy We were asked to improve the ease of donning . Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Parent 2 0 R Support Care Cancer (2020). /Group << Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /Version /1.4 /CS /DeviceRGB >> When I first went to physical therapy, she was running through some more common contibuters to swelling. /F 4 /Annots [10 0 R 11 0 R 12 0 R] 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. >> All reviewers. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. /Contents 73 0 R Toll-free: 1.833.3TACTILE (1.833.382.2845) Hi Wandalynn . Do you know of anyone whom would want to buy it? Support Care Cancer (2020). /A << History of the Northwest Lymphedema Center. Looking at his ankles there IS no swelling now. >> << For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /TT3 72 0 R /W 0 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. Thanks. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. The Flexitouch System is not used for nor intended for use to treat cellulitis. Biomedical Optics Express. endobj /Type /Page >> I have been suffering from lymphedema for the past 2 years. Please write back in a month or so and let us know your progress. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. I would be interested to hear how your husbands experience with his new pump. Words like new kind of pump, different than the old types, favorable studies, and Dr. Then I got my flexitouch and my life changed. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /Filter /FlateDecode It takes just 32 minutes per day. The head & neck of non-human animals - | Cambridge SMART Vocabulary Hi Wally, Hope someone is able to meet your request. /Font << The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. 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. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. It was a blow to the life I had that I once had. /C2_0 21 0 R >> 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. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N /TT0 23 0 R Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. | Source: 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. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Michelin Man came to mind as I stretched out on the couch. The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Your email address will not be published. >> In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /CropBox [0 0 612 792] /XObject << x I was rather startled at how wrapped up I was. I decided to purchase one without insurance. 2 0 obj I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. endobj Ive heard from many people that they saw good results with their pump. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. /URI (http://www.fda.gov/) 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. << Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. I would contact your local news station that has a consumer investigation/help line. /Type /Pages >> +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Adams, KE, Rasmussen JC, Darne C, et al. Its amazing to me how little doctors know about lymphedema. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . /Subtype /Link EJVES. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv /Subtype /Link I have lymphedema near globally at this point and am trying to obtain coverage via insurance. << I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. /TT2 74 0 R /Font << Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Faced with negative publicity, they often end up making things right. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /Type /Action endstream The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Companys control that can make such statements untrue, including, but not limited to, the impacts of the COVID-19 pandemic on the Companys business, financial condition and results of operations; the course of the COVID-19 pandemic and its impact on general economic, business and market conditions; the Companys inability to execute on its plans to respond to the COVID-19 pandemic; the adequacy of the Companys liquidity to pursue its business objectives; the Companys ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives, including prior to identifying a successor; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Companys products; technical problems with the Companys research and products; the Companys ability to expand its business through strategic acquisitions; the Companys ability to integrate acquisitions and related businesses; price increases for supplies and components; the effects of current and future U.S. and foreign trade policy and tariff actions; or the inability to carry out research, development and commercialization plans. Ideas? A healthy lymphatic system moves lymph fluid throughout the body. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. My lymphedema therapist also told me that the pumps werent worth it. endobj Since using the Flexitouch for almost a year, she had not experienced cellulitis. Chronic Wounds See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 Venous Ulcers. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. My interest in pumps suddenly skyrocketed! /TT2 71 0 R Ridner, S.H., Dietrich, M.S., Deng, J. et al. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. 3701 Wayzata Blvd, Suite 300 The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Study record managers: refer to the Data Element Definitions if submitting registration or results information. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Study record managers: refer to the Data Element Definitions if submitting registration or results information. I dont like that I have to do it but it has changed my legs back to normal. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). They will reach out to Flexitouch in the process of creating a segment for the news. /TT0 69 0 R He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. H]O0+=) ES Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. Lymphat Res Biol. /Annots [39 0 R] endobj The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! 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. /Length 412 endobj Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. 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. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /TT0 56 0 R >> 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. Top reviews. >> It takes just 32 minutes per day. >> About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. 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.