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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 use it everyday for an hour. Its brand new, used 1 time. /CropBox [0 0 612 792] This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. 13 0 obj endobj Study record managers: refer to the Data Element Definitions if submitting registration or results information. I used it a few times and Im good now. /Contents 73 0 R I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 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. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 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 << When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Tens of thousands of. Tens of thousands of. /Count 7 /ExtGState << I have lymphedema in my right arm, breast and axilla. My thighs are so big that I can no longer Drive. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). /W 0 I dont like that I have to do it but it has changed my legs back to normal. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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). 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. 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. >> /StructParent 1 I wanted to talk to some people who had actually used the pump. 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? The pump has helped you achieve significant results. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. /Length 412 /URI (http://www.fda.gov/) In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. My husband?s pump system arrived yesterday. >> I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. endobj Dr. Shelia Ridner Dr. Barbara Murphy 3. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. /Font << /F 4 %PDF-1.4 << Surprisingly, my therapists measurements showed minimal difference with previous measurements. /TT0 69 0 R Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Upper set (head and neck). /Tabs /S >> Hi Wandalynn . I just received it yesterday and Im super hopeful that it will help. Keep sharing your story. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /S /Transparency >> Refer to the Legal Notice for express terms of use. Its been tough . Support Care Cancer (2020). A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 7nwJ@6]?t~.} 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. /Type /Page | Source: Pembrolizumab plus cetuximab in patients with recurrent . 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 . An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. I wish you success! )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 endobj << My best to you. Hi Deborah, How wonderful you have had such positive success with your pump. 0 T 2. Swelling will be assessed using the ALOHA measurement protocol. /Parent 2 0 R Why Should I Register and Submit Results? >> 2 0 obj The whole process, though limiting my ambulation, was comfortable and relaxing. Two years on pump controller and garments. << I have skipped 1 or 2 days just 3 or 4 times since March. It takes just 32 minutes per day. Hi Wally, Hope someone is able to meet your request. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. stream JAMA Dermatol. Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. /Length 680 Ml6(|a\!A.;Q#[. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /Parent 2 0 R They are programed for each individual. /CropBox [0 0 612 792] K-ZB: I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck 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. 1. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. They are usually called something like 7 on your side or Channel 3 helps you. /TT2 58 0 R 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Negative value shows a decrease in swelling. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Keep in touch! The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 9 0 obj I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 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. 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. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. All stars. For more information, https://tactilemedical.com/about-us/. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. I am looking for the leg and trunk model is that what you have? >> Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Hopefully it will give me a better quality of life because I dont know what else to do at this point. 15 0 obj 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. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Chronic Wounds /TT2 71 0 R /StructParents 2 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. 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). I had a mastectomy and 9 lymph nodes removed 3 months ago. /TT3 74 0 R The content is not intended to substitute manufacturer instructions. The lymphedema seen in patients treated for head . 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. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /CS /DeviceRGB endobj >> /CropBox [0 0 612 792] You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. 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. . Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. 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 >> And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). First of all I cant drive, and second I have to pay a $60 copay every time I go. 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. Positive value shows an increase in swelling. Positive value shows an increase in symptoms/problems. 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. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. /Rect [40.95 36 85.101 45.216] /Type /Page 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. /Rotate 0 Please remove one or more studies before adding more. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) 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. 17 0 obj 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. endobj >> /Pages 2 0 R endobj I didnt make a decision to purchase a pump that day. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. 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. 2015;151(11):11871193. https://doi.org/10.1007/s00520-020-. 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.. Negative value shows a decrease in quality of life/overall health. /Tabs /S It was a blow to the life I had that I once had. Thank you for sharing your husbands success with a pump. 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. /Rotate 0 Negative value shows a decrease in pain. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Type /Group >> I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Except for my wrist, all my measurements showed reduction. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /C2_0 21 0 R Negative value shows a decrease in Function/Range of Motion. Muluk SC, Hirsch AT, Tafe EC. /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] I cant explain that but I can visually see a difference. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. /Type /Group Many, many of my patients love their pump. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Flexitouch . A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. /Parent 2 0 R /TT0 56 0 R Deng J, et al. /F 4 Lymphat Res Biol. 2010; Vol. My lymphedema therapist also told me that the pumps werent worth it. /URI (http://www.fda.gov/) /Filter /FlateDecode >> << An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 10 0 obj https://doi.org/10.1007/s00520-020-05540-8, 3. /Type /Page /Font << stream Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Parent 2 0 R endobj 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Yay! Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /MediaBox [0.0 0.0 612.0 792.0] /StructParents 0 While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Lymphat Res Biol, 2016. /TT1 70 0 R 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Ideas? It takes just 32 minutes per day. 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 the Flexitouch Plus device.