/TT3 59 0 R Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 2016;14(4):198205. 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.. /CropBox [0.0 0.0 612.0 792.0] /TT1 23 0 R Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. All subjects will receive a single intervention. ? Choosing to participate in a study is an important personal decision. >> O ce they are used the government wont always them to use them on another. 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. They are in contact with patients who could benefit from a pneumatic 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. (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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 10 0 obj /Font << (Note: There are other well regarded pumps on the market. Subject overall health and quality of life in the past week-EORTC C30. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. between head and neck cancer and lymphedema. << endobj Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. 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. stream /S /Transparency >> You have reached the maximum number of saved studies (100). Lymphedema When I first went to physical therapy, she was running through some more common contibuters to swelling. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. endobj Thanks. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. PW!\v(jfz:yX 8$W"wqHbxQDL I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. /Type /Page Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. {%AIqEWRA>, Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. My thighs are so big that I can no longer Drive. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. << 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. Its been tough . )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 | Source: Toll-free: 1.833.3TACTILE (1.833.382.2845) I dont like that I have to do it but it has changed my legs back to normal. Percentage of each response captured. Has anyone else had any experience with this? 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. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Ideas? 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 During pregnancy (applies only to the Flexitouch Plus trunk accessory). 4. So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. I only make 12k per year so its not like I can afford anything. Michelin Man came to mind as I stretched out on the couch. /Resources << For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. My husband?s pump system arrived yesterday. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs /Filter /FlateDecode 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 /BS << Any circumstance where increased lymphatic or venous return is undesirable Numerous garment and program options to meet each patient's unique treatment needs This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. Its something Im passionate about. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. I have one new for sale. According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /Font << Positive value shows an decrease in quality of life. 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. 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. /Type /Action Negative value shows a decrease in pain. /Group << Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. << Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I have skipped 1 or 2 days just 3 or 4 times since March. /Rotate 0 In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. /Type /Action Last updated March 2021. endobj The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 5. 5 0 obj The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. The whole process, though limiting my ambulation, was comfortable and relaxing. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). >> 17 0 obj 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. Last updated March 2021. /Type /Pages Except for my wrist, all my measurements showed reduction. . The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! /Font << G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp The woman from Idaho said her arm was softer and found the machine easy to use. /CropBox [0 0 612 792] Hope it works out. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 1 0 obj Numerous clinical studies show achievement of major clinical benefits and cost savings /GS0 37 0 R Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /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] /Type /Page I really need this system and had such desperate hope. Muluk SC, Hirsch AT, Tafe EC. For more information, https://tactilemedical.com/about-us/. 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. /Tabs /S >> /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 /Tabs /S They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. endobj It has made my life miserable. /MediaBox [0.0 0.0 612.0 792.0] The woman from Idaho said her arm was softer and found the machine easy to use. /Tabs /S I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. 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.. /F 4 Hi Kathi, The FaceTime call might work! /Im0 24 0 R >> The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Managing my lymphedema requires attention and an assortment of tools. Actually they dont know much about lymphedema. It takes just 32 minutes per day. Keep sharing your story. Biomedical Optics Express. It has become so bad that I can barely walk. Explain the situation to them. >> /TT1 57 0 R /F 4 I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. endobj 3701 Wayzata Blvd, Suite 300 /C2_1 55 0 R Breast cancer and treatment in itself was an awful journey. << Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. Why Should I Register and Submit Results? I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. I would suggest you keep contacting Tactile Medical. /Parent 2 0 R Subject Quality of Life will be assessed using EORTC C30 questionnaire. It delivers a noninvasive therapy that patients can administer themselves at home. /CropBox [0 0 612 792] /BS << /Font << I have a uniboot compressions on both of my calves. It takes just 32 minutes per day. Words like new kind of pump, different than the old types, favorable studies, and Dr. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. 2015;151(11):11871193. did you sell it yet? 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. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. 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.
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