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/. /StructParents 6 1 0 obj 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 wonder if pumps can be reprogrammed. endobj 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. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). I dont know if it will make a difference. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Negative value shows a decrease in pain. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. I was rather startled at how wrapped up I was. /Resources << Phone: 1.612.355.5100 The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. 6 0 obj /MediaBox [0.0 0.0 612.0 792.0] k The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. 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 Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. If you still have the system, I am interested. Im sorry for the experience you had with Tactile Medical. /Length 680 Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. I just received it yesterday and Im super hopeful that it will help. Choosing to participate in a study is an important personal decision. When I first went to physical therapy, she was running through some more common contibuters to swelling. Thank you for sharing your husbands success with a pump. >> I use it every evening. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. My husband has a brand new system that Im trying to sell. Negative value shows a increase in quality of life. 5. It delivers a noninvasive therapy that patients can administer themselves at home. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. content.edgar-online.com Hopefully it will give me a better quality of life because I dont know what else to do at this point. stream Its something Im passionate about. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Yes, taking care of ones body requires several interventions. PDF Lauren Barnes - Food and Drug Administration 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. 7nwJ@6]?t~.} /Font << We rely on the generosity of individuals and sponsors who support our mission and activities. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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 Thanks. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. I like to joke, Honey, time for me to put the squeeze on you A Pilot Study to Evaluate the Feasibility and Potential Effectiveness endobj The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. You have reached the maximum number of saved studies (100). See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Flexitouch Plus - Applying the Head and Neck Garment Set endobj 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. You are benefiting the lymphedema community. All stars. /Filter /FlateDecode I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Muluk SC, Hirsch AT, Tafe EC. For general information, Learn About Clinical Studies. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. /C2_0 21 0 R /Type /Page Percent change is calculated by the difference between scores averaged at 6 months versus baseline. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . I would be interested to hear how your husbands experience with his new pump. /CropBox [0.0 0.0 612.0 792.0] I am looking for the leg and trunk model is that what you have? The head & neck of non-human animals - | Cambridge SMART Vocabulary stream Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment /Filter /FlateDecode I have skipped 1 or 2 days just 3 or 4 times since March. >> >> 15 0 obj The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. 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. endstream /Filter /FlateDecode I can relate all too well to what you have been through. tm233510-5_424b5 - none - 7.6719207s Advanced Techniques in Canine and Feline Neurosurgery 7 0 obj << He just never could get use to using it and being able to don the garments. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP {%AIqEWRA>, /Subtype /Link I chatted with a woman from Tacoma and another from Idaho. Its amazing to me how little doctors know about lymphedema. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. I still need to wear night garments and flat knit garmets and compression bras and self MLD but I feel like a weight has been lifted literally and physically. My thighs are so big that I can no longer Drive. /S /URI With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. Support Care Cancer (2020). endobj Oral Oncology. 1. Hi Wally, Hope someone is able to meet your request. Material and methods Design and participants This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. I decided to purchase one without insurance. /Type /Group Learn how your comment data is processed. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. 5 0 obj /Rotate 0 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. /TT3 72 0 R I would contact your local news station that has a consumer investigation/help line. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Explain the situation to them. Has anyone else had any experience with this? 10 0 obj Its been tough . A healthy lymphatic system moves lymph fluid throughout the body. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. I wish you success! Everything in my life that I do and love and I am passionate about invloves using my hands and arms. 0 T She explained that compression pumps force air into sleeves with multiple chambers. 18 0 obj >> 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. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? They are in contact with patients who could benefit from a pneumatic pump. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 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 . << Thank you for sharing and being an advocate for lymphedema! Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. I have a pump system left and right leg also stomach wraps. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I?m 5? Free shipping for many products! /Rotate 0 /C2_0 38 0 R /Type /Page /BS << 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. /Count 7 Lymphat Res Biol, 2016. >> /Parent 2 0 R /Length 498 To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 46(4): 480487. Flexitouch Pd32-u Lymphedema Treatment System Pump >> Text, image, video. Reading or watching TV are the activities Im able to do while Im being treated. Lymphedema stream endobj 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. stream 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Flexitouch Plus - Tactile Medical Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Negative value shows a decrease in symptoms/problems. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. I used it a few times and Im good now. For general information, Learn About Clinical Studies. 4. 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 Hope it works out. 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. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Ridner, S.H., Dietrich, M.S., Deng, J. et al. 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 The pump has helped you achieve significant results. If anyone has one, or knows of one, please contact me. I was told purchased high priced left garments which I dont think I needed. 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) . https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. I really need this system and had such desperate hope. /Group << The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /CropBox [0.0 0.0 612.0 792.0] /TT1 23 0 R Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). It was up to me to piece it together. 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.. /TT1 70 0 R Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /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 Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema Support Care Cancer (2020). In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Ive had my Flexitouch for almost five months. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. << 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Its New, Your email address will not be published. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. 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 . (Clinical Trial). 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. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 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. Flexitouch . During pregnancy (applies only to the Flexitouch Plus trunk accessory). 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 ] /Rotate 0 Minneapolis, MN 55416 USA << 2. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Support Care Cancer (2020). /Parent 2 0 R 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 . /ProcSet [/PDF /Text /ImageC] For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. Out of my sleeve, my 3/4 length sleeves arent as tight. /S /URI 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. How customer reviews and ratings work See All Buying Options. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. 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. /BS << Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Hi Wandalynn . https://doi.org/10.1007/s00520-020-. I didnt need a lymphedema physical therapist but too much to explain here. /XObject << I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. What is encouraging is that you have had success with managing your lymphedema! 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. /CropBox [0.0 0.0 612.0 792.0] /Type /Group 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Resources << Flexitouch Pd32-u Lymphedema Treatment System Pump. between head and neck cancer and lymphedema. Last updated March 2021. Lymphedema Treatment in Head and Neck Cancer Patients /Tabs /S Hi Kathi, The FaceTime call might work! 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. 12 0 obj 1. /Font << 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. I only make 12k per year so its not like I can afford anything. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Hi Kristie, Thank you for sharing your story. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch Adams, KE, Rasmussen JC, Darne C, et al. 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. did you sell it yet? Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. (6Kjw_XGz'g &p /TT2 51 0 R >> Filter by. /Filter /FlateDecode Support Care Cancer (, 2020). /S /URI /Type /Page /CropBox [0.0 0.0 612.0 792.0] Try contacting different people. I have a uniboot compressions on both of my calves. 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. My skin appears more like the skin on my right arm. (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. /A << Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. So we appealed 3 times. /Tabs /S Advanced pneumatic compression for treatment of lymphedema of the head I greatly encourage others to try to obtain one if they are able and if it is a good option for them. Flexitouch Plus - Treat Head & Neck Swelling At Home with This UGH! First of all I cant drive, and second I have to pay a $60 copay every time I go. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /TT2 72 0 R As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. endobj Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002.