/Font << 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. Top reviews. All reviewers. Write a review. /Annots [10 0 R 11 0 R 12 0 R] +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Please remove one or more studies before adding more. /A << Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /Resources << Adams, KE, Rasmussen JC, Darne C, et al. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. For more information, https://tactilemedical.com/about-us/. /Parent 2 0 R [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. It delivers a noninvasive therapy that patients can administer themselves at home. Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. Support Care Cancer (2020). Rz:MzI6 >> Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Two years on pump controller and garments. >> >> The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. /Rotate 0 Minneapolis, MN 55416 USA Positive value shows an increase in swelling. Reading or watching TV are the activities Im able to do while Im being treated. It delivers a noninvasive therapy that patients can administer themselves at home. You are benefiting the lymphedema community. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 /Filter /FlateDecode Hi Kristie, Thank you for sharing your story. Flexitouch Pd32-u Lymphedema Treatment System Pump. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. I dont know if it will make a difference. I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. Support Care Cancer (2020). stream I am delighted to say that hubbys minor leg swelling, from his diabetes and hefty build, are significantly less after Flexi-Touch was added to his health regime by the Diabetes Clinic at the VA Hospital. /W 0 /XObject << The content is not intended to substitute manufacturer instructions. Words like new kind of pump, different than the old types, favorable studies, and Dr. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Overview Product Features Details Benefits 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. << Numerous garment and program options to meet each patient's unique treatment needs 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. Positive value shows an increase in quality of life/overall health. They use them in the morning, at nightand feel very lucky.. Type of Use (Select one or both, as applicable) lXI . 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. /CS /DeviceRGB I was rather startled at how wrapped up I was. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. 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. /Type /Page endobj An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. << https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. endobj << My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. It takes just 32 minutes per day. /BS << 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /TT3 52 0 R & weigh 126 lbs. Hopefully it will give me a better quality of life because I dont know what else to do at this point. /TT1 50 0 R Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. If anyone has one, or knows of one, please contact me. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. 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. /TT0 49 0 R Negative value shows a decrease in Function/Range of Motion. endobj Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /F 4 If Im out late, I use it in the morning and then resume again in the evening. Another set of pads enveloped my left thigh and trunk. I need help but theres a no return policy. endobj stream /Font << /Length 470 Many, many of my patients love their pump. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Ml6(|a\!A.;Q#[. Learn More Take the steps now to help your head and neck cancer survivors. 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 ] 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. /Group << /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] 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. /Contents 75 0 R History of the Northwest Lymphedema Center. Rockson floated to my ears. My skin appears more like the skin on my right arm. I have skipped 1 or 2 days just 3 or 4 times since March. So for almost every night for the next seven years I sat down and performed MLD on my left arm. 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. Hi Deborah, How wonderful you have had such positive success with your pump. Since using the Flexitouch for almost a year, she had not experienced cellulitis. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Venous Ulcers. /Font << I wanted to talk to some people who had actually used the pump. Ridner, S.H., Dietrich, M.S., Deng, J. et al. endobj I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. I use it every evening. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ So we appealed 3 times. 4 0 obj << The whole process, though limiting my ambulation, was comfortable and relaxing. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. /GS0 37 0 R Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /Length 498 Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. >> Hi Karyn, I will post your comment and see if Sarah still has the pump available. Its amazing how we are communicating so much more through technology because of Covid. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Resources << Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. >> 46(4): 480487. endobj /Length 450 . Lymphedema FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. It delivers a noninvasive therapy that patients can administer themselves at home. D/N500187-000-00 Rev. /Count 7 Yes. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /Filter /FlateDecode Ideas? They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. 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) . Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /ProcSet [/PDF /Text] Thank you for sharing your husbands success with a pump. 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 . endstream Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /CropBox [0.0 0.0 612.0 792.0] (Clinical Trial). . >> 9 0 obj Toll-free: 1.833.3TACTILE (1.833.382.2845) 18 0 obj >> They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. Thank you for writing. /S /URI trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. 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? /C2_0 54 0 R One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. They will reach out to Flexitouch in the process of creating a segment for the news. 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. 6 0 obj Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. They are in contact with patients who could benefit from a pneumatic pump. 16 0 obj Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. It has become so bad that I can barely walk. 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/. >> >> /Resources << Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. I really need this system and had such desperate hope. 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. He just never could get use to using it and being able to don the garments. I have little confidence that the FaceTime call offered will be of much use. 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. Yes, taking care of ones body requires several interventions. /Type /Page /CS /DeviceRGB Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). >> 11 0 obj Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. 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. /S /Transparency Ridner, S.H., Dietrich, M.S., Deng, J. et al. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. 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. Keep in touch! I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. I have a pump system left and right leg also stomach wraps. The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. I dont like that I have to do it but it has changed my legs back to normal. >> endobj 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. (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. 14(4): p. 198-205, 2. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency I?m 5? >> >> Material and methods Design and participants I just received the flexitouch plus, but I think the leg garments are too big. %PDF-1.4 My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 8 0 obj A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. /TT0 69 0 R /Rotate 0 Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Muluk SC, Hirsch AT, Tafe EC. Choosing to participate in a study is an important personal decision. /TT0 56 0 R A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Free shipping for many products! I like to joke, Honey, time for me to put the squeeze on you It seems a lot of pumps are preprogrammed for the individual. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 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. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. >> Toll-free: 1.833.3TACTILE (1.833.382.2845) I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). Text, image, video. 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. /Filter /FlateDecode A healthy lymphatic system moves lymph fluid throughout the body. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 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! << /Pages 2 0 R The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. 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. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 3701 Wayzata Blvd, Suite 300 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. << I did send them an email and asked them to look at your case again. 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 To pump or not to pumpthat is a question that I hear in the lymphedema community. 2013; Vol. Deng J, et al. /F 4 /Resources << Its also a relief not to manually MLD my arm every night. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Most significantly was the reduction in my forearm. /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] Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 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. >> I didnt need a lymphedema physical therapist but too much to explain here. Negative value shows a increase in quality of life. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. /Rotate 0 The woman from Idaho said her arm was softer and found the machine easy to use. /S /Transparency Managing my lymphedema requires attention and an assortment of tools. Any circumstance where increased lymphatic or venous return is undesirable /Group << I cant explain that but I can visually see a difference. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Negative value shows a decrease in pain. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now.
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