O ce they are used the government wont always them to use them on another. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Flexitouch . 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. Deng J, et al. First of all I cant drive, and second I have to pay a $60 copay every time I go. /Tabs /S I used it a few times and Im good now. Support Care Cancer (, 2020). 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /TT1 70 0 R The Flexitouch System is not used for nor intended for use to treat cellulitis. 14 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. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. EJVES. I know many others can as well. /S /Transparency Tactile Systems Technology (TCMD +0.6%) announces the enrollment of the first patient in a randomized, controlled trial evaluating the effectiveness of its Flexitouch Plus system for the treatment . >> It was up to me to piece it together. For general information, Learn About Clinical Studies. endobj I was told purchased high priced left garments which I dont think I needed. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. /Count 7 Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /MediaBox [0 0 612 792] My best to you. /CropBox [0.0 0.0 612.0 792.0] /Font << In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. I dont know if it will make a difference. During pregnancy (applies only to the Flexitouch Plus trunk accessory). The woman from Idaho said her arm was softer and found the machine easy to use. /Font << << /Tabs /S Muluk SC, Hirsch AT, Tafe EC. << /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 I didnt make a decision to purchase a pump that day. /StructParents 0 I have little confidence that the FaceTime call offered will be of much use. I decided to purchase one without insurance. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /Font << Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /TT0 56 0 R Thanks. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? I was rather startled at how wrapped up I was. >> 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. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Type /Page Listing a study does not mean it has been evaluated by the U.S. Federal Government. This is not anadvertisement for Flexitouch.). I would be interested to hear how your husbands experience with his new pump. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. 1. Phone: 1.612.355.5100 1. I have skipped 1 or 2 days just 3 or 4 times since March. Im sorry for the experience you had with Tactile Medical. 2. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. >> I wish you success! & weigh 126 lbs. Ml6(|a\!A.;Q#[. 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. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Filter by. 46(4): 480487. /MediaBox [0.0 0.0 612.0 792.0] 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. 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. endobj /Rect [40.95 36 85.101 45.216] Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. /CropBox [0.0 0.0 612.0 792.0] It delivers a noninvasive therapy that patients can administer themselves at home. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. /Length 498 Many head and neck cancer survivors are faced with an additional challenge: lymphedema. 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 /Rotate 0 13 0 obj /Rotate 0 Support Care Cancer (2020). Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 9 0 obj My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. Last updated March 2021. It delivers a noninvasive therapy that patients can administer themselves at home. UGH! Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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. Negative value shows a increase in quality of life. Its amazing how we are communicating so much more through technology because of Covid. /BS << During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. The whole process, though limiting my ambulation, was comfortable and relaxing. I have lymphedema in my right arm, breast and axilla. /Parent 2 0 R Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical S Yay! Deng J, et al. It takes just 32 minutes per day. PW!\v(jfz:yX 8$W"wqHbxQDL Its brand new, used 1 time. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource << Type of Use (Select one or both, as applicable) lXI . /Parent 2 0 R /Filter /FlateDecode I like to joke, Honey, time for me to put the squeeze on you 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. They are programed for each individual. 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. 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. /Filter /FlateDecode I am looking for a left arm garment for the flexitouch plus. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. Lymphat Res Biol. It has made my life miserable. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. (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. /F 4 Thank you for sharing your husbands success with a pump. >> x ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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 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. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. 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. /Length 585 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. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . 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 . Another set of pads enveloped my left thigh and trunk. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. >> /TT0 23 0 R /CS /DeviceRGB Biomedical Optics Express. Oral Oncology. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Positive value shows an increase in symptoms/problems. 2 0 obj /StructParents 2 endstream To pump or not to pumpthat is a question that I hear in the lymphedema community. /StructParents 0 I have been suffering from lymphedema for the past 2 years. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. . 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.. >> The feeling of devloping a chronic disease after surviving cancer was almost debilitating. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 Refer to the Legal Notice for express terms of use. (Note: There are other well regarded pumps on the market. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. >> << The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. For more information, https://tactilemedical.com/about-us/. 2. /F 4 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! /StructParent 1 /Font << endobj stream 8 0 obj 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. 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. /Pages 2 0 R Its something Im passionate about. I just received the flexitouch plus, but I think the leg garments are too big. Medical Device Innovation | Nottingham Spirk Design Collaborative 10 0 obj What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Im only 44 years old , and I have kids that need mom back. Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials /Contents 75 0 R 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. Your email address will not be published. Flexitouch Pd32-u Lymphedema Treatment System Pump. >> What really gripes me is that my nurse practitioner wouldnt even consider ordering one. /Type /Action She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. 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 Pembrolizumab plus cetuximab in patients with recurrent . Our Solutions for Head and Neck - Tactile Medical 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. /Font << endobj https://doi.org/10.1007/s00520-020-. XJ Managing my lymphedema requires attention and an assortment of tools. 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. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. Tactile Systems Technology, Inc. /S /URI Toll-free: 1.833.3TACTILE (1.833.382.2845) The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. I have it in both of my legs mostly in my thighs. >> I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. >> You have reached the maximum number of saved studies (100). Please cross your fingers for me that this works. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 17 0 obj Do you know of anyone whom would want to buy it? >> Percentage of each response captured. My therapist said they cannot be reused by another. Out of my sleeve, my 3/4 length sleeves arent as tight. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. >> We were asked to improve the ease of donning . 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. I am looking for the leg and trunk model is that what you have? Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. It has become so bad that I can barely walk. Minneapolis, MN 55416 USA Flexitouch Plus - Applying the Head and Neck Garment Set Positive value shows an increase in Function/Range of Motion. /TT3 59 0 R Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. A Pilot Study to Evaluate the Feasibility and Potential Effectiveness 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. phone: +1 (623) 738-9011 (57) Webstore 3. /TT2 58 0 R While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Buying a reconditioned machine saved me some money. (6Kjw_XGz'g &p Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. tm233510-5_424b5 - none - 7.6719207s Then I got my flexitouch and my life changed. Last updated March 2021. 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. Overview Product Features Details Benefits +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Heart failure (acute pulmonary edema, decompensated acute heart failure) 2013; Vol. Except for my wrist, all my measurements showed reduction. /Subtype /Link did you sell it yet? When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. Flexitouch Plus provides flexible program options. 2010; Vol. /MediaBox [0.0 0.0 612.0 792.0] /Group << Thank you for sharing and being an advocate for lymphedema! /TT2 51 0 R The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 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. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. << Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /Rect [40.95 36 85.101 45.216] Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. The head & neck of non-human animals - << 14(4): p. 198-205, 2. /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] Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Ridner, S.H., Dietrich, M.S., Deng, J. et al. 3 0 obj Positive value shows an decrease in quality of life. I have been having weekly physical therapy to help with lymphedema and range of motion issues. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. All stars. >> The warranty was the same as a new machine. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /Parent 2 0 R /TT0 49 0 R He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. /StructParents 6 /Parent 2 0 R Just wondering if you have any ideas of whom to contact on such a thing. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 12 0 obj A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. Material and methods Design and participants Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 2008-2023 HMP Global, Inc. All rights reserved. /Rotate 0 Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. You have reached the maximum number of saved studies (100). 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. So we appealed 3 times. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. My insurance paid for all of it and the Tactile rep will help you get that. Lymphat Res Biol, 2016. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. << Rz:MzI6 Sign up today for your free Reader Account. /Im0 24 0 R Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? 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. stream Faced with negative publicity, they often end up making things right. Ideas? Can I use the machine on lower limbs with compression garments above? >> I did send them an email and asked them to look at your case again. 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 [13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 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.