/Rotate 0 16 0 obj 35 0 R] Material and methods Design and participants /MediaBox [0 0 612 792] /S /Transparency We were asked to improve the ease of donning . /Contents 53 0 R 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. My husband has a brand new system that Im trying to sell. 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. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 2. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /Type /Page where is the compassion for ill people that NEED certain healthcare to get better? Out of my sleeve, my 3/4 length sleeves arent as tight. My therapist said they cannot be reused by another. Muluk SC, Hirsch AT, Tafe EC. Toll-free: 1.833.3TACTILE (1.833.382.2845) Numerous garment and program options to meet each patient's unique treatment needs This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. >> /Length 450 Support Care Cancer (2020). Its amazing to me how little doctors know about lymphedema. 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. /Contents 73 0 R /Type /Catalog My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /CropBox [0.0 0.0 612.0 792.0] 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. 3701 Wayzata Blvd, Suite 300 Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. They are in contact with patients who could benefit from a pneumatic pump. I didnt need a lymphedema physical therapist but too much to explain here. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. between head and neck cancer and lymphedema. 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. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment >> 2010; Vol. D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, 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/. )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 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. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Minneapolis, MN 55416 USA In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. endobj I cant explain that but I can visually see a difference. endobj /Parent 2 0 R /Rotate 0 /ProcSet [/PDF /Text] I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. /Contents 36 0 R /URI (http://www.fda.gov/) /Type /Action Yes. Negative value shows a decrease in pain. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 1. endstream >> Swelling will be assessed using the ALOHA measurement protocol. /Parent 2 0 R I wonder if pumps can be reprogrammed. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. I have a uniboot compressions on both of my calves. I?m 5? HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). Tens of thousands of. Minneapolis, MN 55416 USA /Type /Page /TT1 70 0 R endobj Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). I just received the flexitouch plus, but I think the leg garments are too big. Im sorry for the experience you had with Tactile Medical. 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. The woman from Idaho said her arm was softer and found the machine easy to use. >> I can relate all too well to what you have been through. I know many others can as well. Lymphat Res Biol. /Rect [40.95 36 85.101 45.216] XJ Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. History of the Northwest Lymphedema Center. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Its been tough . endobj /Length 412 During pregnancy (applies only to the Flexitouch Plus trunk accessory). 5 0 obj 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. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 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. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. 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. Required fields are marked *. >> Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Oral Oncology. /Im0 24 0 R Positive value shows an increase in pain. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. Thanks. ? HTo0~G6)BjH7u >> Deng J, et al. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /XObject << /Tabs /S (Note: There are other well regarded pumps on the market. Talk with your doctor and family members or friends about deciding to join a study. >> 2. [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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /TT3 52 0 R I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . /StructParents 8 Overview Product Features Details Benefits >> https://doi.org/10.1007/s00520-020-. If anyone has one, or knows of one, please contact me. 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. /TT0 49 0 R /CropBox [0 0 612 792] << Talk with your doctor and family members or friends about deciding to join a study. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. 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. * American Society of Clinical Oncology 1. endobj >> 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. by Flexitouch. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Then I got my flexitouch and my life changed. The pump has helped you achieve significant results. If Im out late, I use it in the morning and then resume again in the evening. I did send them an email and asked them to look at your case again. /Resources << Venous Ulcers. /Resources << /TT0 23 0 R Except for my wrist, all my measurements showed reduction. /W 0 1 0 obj /Resources << Ridner, S.H., Dietrich, M.S., Deng, J. et al. % Its brand new, used 1 time. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. >> Keep sharing your story. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I use it every evening. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. endobj Managing my lymphedema requires attention and an assortment of tools. /TT1 57 0 R I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. JAMA Dermatol. /Type /Page In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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? You are benefiting the lymphedema community. 11 0 obj /C2_0 54 0 R /Group << Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. 17 0 obj Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /Rotate 0 I have lymphedema in my right arm, breast and axilla. I knew Dr. Stanley Rockson of Stanford University was performing a drug trial with a medication called Uberimex for the treatment of lymphedema so I was keenly interested in learning what he said about this new pump. I have been suffering from lymphedema for the past 2 years. Another set of pads enveloped my left thigh and trunk. Learn how your comment data is processed. /TT0 22 0 R My husband?s pump system arrived yesterday. 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. endstream Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) My go to place when I need calming. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Please remove one or more studies before adding more. It was a blow to the life I had that I once had. Free shipping for many products! You have reached the maximum number of saved studies (100). Two years on pump controller and garments. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /CropBox [0.0 0.0 612.0 792.0] endstream He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. endobj /C2_0 38 0 R >> /A << Ive heard from many people that they saw good results with their pump. /F 4 Hi Deborah, How wonderful you have had such positive success with your pump. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Positive value shows an decrease in quality of life. /Tabs /S 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. Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. Its something Im passionate about. /S /URI 2013; Vol. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with >> I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. My lymphedema therapist also told me that the pumps werent worth it. 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. /TT1 23 0 R Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. I cannot find any shoes that fit my feet or any pants that fit comfortably . Do you know of anyone whom would want to buy it? >> While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /A << They are usually called something like 7 on your side or Channel 3 helps you. Has anyone else had any experience with this? 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. 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/.
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