>> Clinical Trial on Head and Neck Cancer: Flexitouch Plus system NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( September 30, 2021 09:03 ET Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Dr. Shelia Ridner Dr. Barbara Murphy /Type /Page 7 0 obj >> I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. /Length 498 Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. They are in contact with patients who could benefit from a pneumatic pump. /Filter /FlateDecode Advanced pneumatic compression for treatment of lymphedema of the head To pump or not to pumpthat is a question that I hear in the lymphedema community. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /Filter /FlateDecode Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Study record managers: refer to the Data Element Definitions if submitting registration or results information. /Rotate 0 Muluk SC, Hirsch AT, Tafe EC. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Resources << Last updated March 2021. https://doi.org/10.1007/s00520-020-. /Font << Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 3. /Parent 2 0 R It delivers a noninvasive therapy that patients can administer themselves at home. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /S /URI The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. /Type /Group Minneapolis, MN 55416 USA Do you know of anyone whom would want to buy it? 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. 7nwJ@6]?t~.} /Type /Action History of the Northwest Lymphedema Center. 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/. Toll-free: 1.833.3TACTILE (1.833.382.2845) For more information, https://tactilemedical.com/about-us/. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. EJVES. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. It has made my life miserable. Tactile Medical Announces Enrollment of First Patient in - Yahoo! While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. All subjects will receive a single intervention. >> https://doi.org/10.1007/s00520-020-05540-8, 3. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? Positive value shows an increase in symptoms/problems. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /ProcSet [/PDF /Text] Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endobj PW!\v(jfz:yX 8$W"wqHbxQDL According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. 11 0 obj For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. /MediaBox [0.0 0.0 612.0 792.0] >> Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? * American Society of Clinical Oncology 1. You have reached the maximum number of saved studies (100). +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP I have been suffering from lymphedema for the past 2 years. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. << My insurance paid for all of it and the Tactile rep will help you get that. 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. 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. Its been tough . >> Its amazing how we are communicating so much more through technology because of Covid. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. << My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 3 0 obj Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /Tabs /S The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Just wondering if you have any ideas of whom to contact on such a thing. /StructParent 1 Biomedical Optics Express. /TT2 71 0 R Oral Oncology. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. My husband?s pump system arrived yesterday. 17 0 obj stream . >> Reading or watching TV are the activities Im able to do while Im being treated. Actually they dont know much about lymphedema. endstream 2015 51 (431-437), 1. Two years on pump controller and garments. Phone: 1.612.355.5100 2 0 obj The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Please remove one or more studies before adding more. 2013; Vol. I have a uniboot compressions on both of my calves. % Tactile Medical braces for new Medicare rules that will tighten access /TT0 23 0 R Yay! << /S /Transparency 46(4): 480487. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /Group << In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. endobj << 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. 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. The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! 13 0 obj G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 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. Positive value shows an increase in swelling. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. I like to joke, Honey, time for me to put the squeeze on you Refer to the Legal Notice for express terms of use. 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 . doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Hi Kathi, The FaceTime call might work! 5. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use I wonder if pumps can be reprogrammed. Tactile Systems Technology, Inc. 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. Percentage of each response captured. /Resources << HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. The warranty was the same as a new machine. First of all I cant drive, and second I have to pay a $60 copay every time I go. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. It delivers a noninvasive therapy that patients can administer themselves at home. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. News Release Details - Tactile Systems Technology, Inc. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Its New, Your email address will not be published. I would contact your local news station that has a consumer investigation/help line. 15 0 obj endobj /Subtype /Link 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. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time It delivers a noninvasive therapy that patients can administer themselves at home. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Tens of thousands of. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. 2016;14(4):198205. 8 0 obj {%AIqEWRA>, 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. (6Kjw_XGz'g &p Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. I have a pump system left and right leg also stomach wraps. Lymphat Res Biol, 2016. 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.