The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. << 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. 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. Minneapolis, MN 55416 USA +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP 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 Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /Rotate 0 >> >> Material and methods Design and participants The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. My skin appears more like the skin on my right arm. This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. >> I have a pump system left and right leg also stomach wraps. bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ The woman from Idaho said her arm was softer and found the machine easy to use. I am looking for the leg and trunk model is that what you have? >> Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? 46(4): 480487. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. /Parent 2 0 R stream They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. /Contents 36 0 R /XObject << 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. They are programed for each individual. Hope it works out. 5. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Ive heard from many people that they saw good results with their pump. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The warranty was the same as a new machine. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /TT0 56 0 R The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. phone: +1 (623) 738-9011 (57) Webstore 3. All subjects will receive a single intervention. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Choosing to participate in a study is an important personal decision. /Type /Page 3 0 obj 2010; Vol. S 6 0 obj << Most significantly was the reduction in my forearm. They are in contact with patients who could benefit from a pneumatic pump. Negative value shows a decrease in swelling. 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. What is encouraging is that you have had success with managing your lymphedema! Choosing to participate in a study is an important personal decision. She explained that compression pumps force air into sleeves with multiple chambers. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. 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. /MediaBox [0 0 612 792] 4 0 obj >> >> 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. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /Type /Group Out of my sleeve, my 3/4 length sleeves arent as tight. It was up to me to piece it together. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. Free shipping for many products! Search. I was rather startled at how wrapped up I was. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs /Rotate 0 /Rotate 0 September 30, 2021 09:03 ET 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. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Thank you for writing. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 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.. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Thanks. All reviewers. /CropBox [0.0 0.0 612.0 792.0] PW!\v(jfz:yX 8$W"wqHbxQDL Phone: 1.612.355.5100 Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. Refer to the Legal Notice for express terms of use. 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. << endobj I would contact your local news station that has a consumer investigation/help line. /Font << Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. << The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Yes. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. 1 0 obj >> Hi Deborah, How wonderful you have had such positive success with your pump. Your email address will not be published. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. Adams, KE, Rasmussen JC, Darne C, et al. {%AIqEWRA>, 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. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /TT1 57 0 R 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. >> Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). /C2_1 55 0 R I really need this system and had such desperate hope. Required fields are marked *. /Type /Catalog endstream Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. [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. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. stream 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. did you sell it yet? If you still have the system, I am interested. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Upper set (head and neck). The content is not intended to substitute manufacturer instructions. 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. 2016;14(4):198205. It delivers a noninvasive therapy that patients can administer themselves at home. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. The Head & Neck Program is just 32 minutes long. 1. 2015;151(11):11871193. >> Oral Oncology. 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. /S /URI Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 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. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 4. The lymphedema seen in patients treated for head . I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. /URI (http://www.fda.gov/) Lymphat Res Biol. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Companys control that can make such statements untrue, including, but not limited to, the impacts of the COVID-19 pandemic on the Companys business, financial condition and results of operations; the course of the COVID-19 pandemic and its impact on general economic, business and market conditions; the Companys inability to execute on its plans to respond to the COVID-19 pandemic; the adequacy of the Companys liquidity to pursue its business objectives; the Companys ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives, including prior to identifying a successor; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Companys products; technical problems with the Companys research and products; the Companys ability to expand its business through strategic acquisitions; the Companys ability to integrate acquisitions and related businesses; price increases for supplies and components; the effects of current and future U.S. and foreign trade policy and tariff actions; or the inability to carry out research, development and commercialization plans. >> This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. I wanted to talk to some people who had actually used the pump. /Parent 2 0 R >> /F 4 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 . >> %PDF-1.4 /Type /Action The pump is called the Flexitouch System by Tactile Medical. Two years on pump controller and garments. Its amazing to me how little doctors know about lymphedema. /Rect [90.257 252.64 421.33 266.44] Im only 44 years old , and I have kids that need mom back. I dont like that I have to do it but it has changed my legs back to normal. << Since using the Flexitouch for almost a year, she had not experienced cellulitis. 0 T endobj >> So we appealed 3 times. Keep in touch! We rely on the generosity of individuals and sponsors who support our mission and activities. 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 of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) >> Tens of thousands of. 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. /Tabs /S 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. 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. /Resources << Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. My interest in pumps suddenly skyrocketed! UGH! /ProcSet [/PDF /Text /ImageC] I decided to purchase one without insurance. /MediaBox [0 0 612 792] You have reached the maximum number of saved studies (100). stream 35 0 R] >> /CS /DeviceRGB 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. /TT1 23 0 R Surprisingly, my therapists measurements showed minimal difference with previous measurements. Why Should I Register and Submit Results? I dont know if it will make a difference. They are usually called something like 7 on your side or Channel 3 helps you. endstream Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. 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. 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. Hopefully it will give me a better quality of life because I dont know what else to do at this point. Please cross your fingers for me that this works. endstream 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. /Type /Page In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Positive value shows an increase in Function/Range of Motion. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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. /Tabs /S Flexitouch Plus provides flexible program options. Sort by. It was a blow to the life I had that I once had. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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. /Tabs /S /C2_0 38 0 R I just received it yesterday and Im super hopeful that it will help. /A << /Im0 24 0 R 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I have one new for sale. Ideas? 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.. 1. /TT1 50 0 R I always start with the one hour full arm and core setting. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Tens of thousands of. 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 woman from Idaho said her arm was softer and found the machine easy to use. Any circumstance where increased lymphatic or venous return is undesirable 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. The head & neck of non-human animals - | Cambridge SMART Vocabulary I didnt need a lymphedema physical therapist but too much to explain here. My go to place when I need calming. It delivers a noninvasive therapy that patients can administer themselves at home. /Font << Hi Kathi, The FaceTime call might work! 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. between head and neck cancer and 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. I have been having weekly physical therapy to help with lymphedema and range of motion issues. I need help but theres a no return policy. endobj 14(4): p. 198-205, 2. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! >> JAMA Dermatol. EJVES. I would be interested to hear how your husbands experience with his new pump. >> 3. >> /CS /DeviceRGB document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Type /Action To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. /Count 7 /Length 412 I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. Negative value shows a decrease in symptoms/problems. Looking at his ankles there IS no swelling now. /CropBox [0.0 0.0 612.0 792.0] Hi Karyn, I will post your comment and see if Sarah still has the pump available. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /TT0 69 0 R << (Clinical Trial). /Annots [39 0 R] I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. )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 swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. 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.
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