flexitouch plus head and neck

endobj Faced with negative publicity, they often end up making things right. /Resources << Study record managers: refer to the Data Element Definitions if submitting registration or results information. If you still have the system, I am interested. 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. /A << Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. 14 0 obj & weigh 126 lbs. << 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. 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. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Negative value shows a decrease in symptoms/problems. Hi Karyn, I will post your comment and see if Sarah still has the pump available. Michelin Man came to mind as I stretched out on the couch. endobj HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /Type /Group 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. All reviewers. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. endobj Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 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! stream I chatted with a woman from Tacoma and another from Idaho. 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. /Group << Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. Its brand new, used 1 time. (Note: There are other well regarded pumps on the market. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional >> 4. Thanks. Your email address will not be published. stream While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. EJVES. Hi Deborah, How wonderful you have had such positive success with your pump. >> I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 6 0 obj 16 0 obj (Clinical Trial). Ridner, S.H., Dietrich, M.S., Deng, J. et al. Hi Wally, Hope someone is able to meet your request. My husband?s pump system arrived yesterday. >> /MediaBox [0 0 612 792] Support Care Cancer (2020). It has made my life miserable. I just received it yesterday and Im super hopeful that it will help. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 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. >> >> document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. 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) >> Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Its amazing how we are communicating so much more through technology because of Covid. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. H]O0+=) ES >> 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. I cannot find any shoes that fit my feet or any pants that fit comfortably . /TT1 57 0 R Free shipping for many products! /Contents 75 0 R . 14(4): p. 198-205. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. 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/. Ive heard from many people that they saw good results with their pump. /Type /Pages /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N endobj Two years on pump controller and garments. 5 0 obj This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. They use them in the morning, at nightand feel very lucky.. Top reviews. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. 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^ S Try contacting different people. 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. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( >> Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /C2_0 38 0 R This is not anadvertisement for Flexitouch.). Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /Filter /FlateDecode /ProcSet [/PDF /Text] I use it every evening. /Tabs /S Tens of thousands of. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I was told purchased high priced left garments which I dont think I needed. Out of my sleeve, my 3/4 length sleeves arent as tight. September 30, 2021 09:03 ET >> 5. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs Im sorry for the experience you had with Tactile Medical. 2015;151(11):11871193. https://doi.org/10.1007/s00520-020-. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 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. /Resources << Lymphat Res Biol. Explain the situation to them. Negative value shows a decrease in swelling. 4 0 obj 3701 Wayzata Blvd, Suite 300 /Font << Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /F 4 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. /Type /Action And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. 2. The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. 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. Text, image, video. You are benefiting the lymphedema community. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Support Care Cancer (2020). Chronic Wounds Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 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. (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. Why Should I Register and Submit Results? /Font << Lymphat Res Biol. 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. I didnt make a decision to purchase a pump that day. >> ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN I didnt need a lymphedema physical therapist but too much to explain here. Numerous garment and program options to meet each patient's unique treatment needs endstream Thumbs up for Flexi-Touch!! stream Just wondering if you have any ideas of whom to contact on such a thing. Rz:MzI6 https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Toll-free: 1.833.3TACTILE (1.833.382.2845) I have skipped 1 or 2 days just 3 or 4 times since March. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Rotate 0 Phone: 1.612.355.5100 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. Any circumstance where increased lymphatic or venous return is undesirable /TT0 49 0 R I have little confidence that the FaceTime call offered will be of much use. 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! My interest in pumps suddenly skyrocketed! The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use It takes just 32 minutes per day. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. [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. /Length 470 by Flexitouch. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /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] /Contents 53 0 R Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. 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. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 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.. endobj /ExtGState << 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. /Parent 2 0 R Toll-free: 1.833.3TACTILE (1.833.382.2845) /StructParents 8 >> Pembrolizumab plus cetuximab in patients with recurrent . /Parent 2 0 R 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. Yay! Ideas? The Flexitouch System is not used for nor intended for use to treat cellulitis. /S /Transparency The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. /Font << When she said piano I froze. /TT0 69 0 R /Rotate 0 What really gripes me is that my nurse practitioner wouldnt even consider ordering one. 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 /Resources << 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. She explained that compression pumps force air into sleeves with multiple chambers. /MediaBox [0.0 0.0 612.0 792.0] Its amazing to me how little doctors know about lymphedema. 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. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Thanks. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. How customer reviews and ratings work See All Buying Options. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Many, many of my patients love their pump. I would be interested to hear how your husbands experience with his new pump. /Type /Page Heart failure (acute pulmonary edema, decompensated acute heart failure) The Head & Neck Program is just 32 minutes long. 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) . endobj /StructParents 2 /TT0 56 0 R As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. Im a pianist and its become my safe place. /Length 412 The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /Type /Page I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. 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. /Type /Group /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] did you sell it yet? 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 ] 17 0 obj I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. >> Thank you for writing. During pregnancy (applies only to the Flexitouch Plus trunk accessory). Actually they dont know much about lymphedema. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. Dr. Shelia Ridner Dr. Barbara Murphy K-ZB: Positive value shows an increase in Function/Range of Motion. Breast cancer and treatment in itself was an awful journey. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /Tabs /S << /Version /1.4 >> For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. You have reached the maximum number of saved studies (100). 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. Keep sharing your story. 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. Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. 3701 Wayzata Blvd, Suite 300 /StructParents 7 /MediaBox [0.0 0.0 612.0 792.0] This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. /C2_0 54 0 R 4? endobj Both Ease of Use/Satisfaction will be assessed by survey. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. 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. 2 0 obj Negative value shows a increase in quality of life. 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. endstream Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. endobj 9 0 obj I wanted to talk to some people who had actually used the pump. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Pain will be assessed using the VAS Pain Scale. We were asked to improve the ease of donning . >> << Sign up today for your free Reader Account. /S /URI << >> /Parent 2 0 R eIb? /Type /Page /Contents 36 0 R Muluk SC, Hirsch AT, Tafe EC. /Im0 24 0 R /Contents 73 0 R 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. 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). /BS << << 2. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /BS << He just never could get use to using it and being able to don the garments. /Length 450 I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. 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. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. 2008-2023 HMP Global, Inc. All rights reserved. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Subject Quality of Life will be assessed using EORTC C30 questionnaire. I can relate all too well to what you have been through. /TT2 74 0 R /Resources << 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. 1(1): 114125. /MediaBox [0.0 0.0 612.0 792.0] << Refer to the Legal Notice for express terms of use. I have a pump system left and right leg also stomach wraps. >> In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Its something Im passionate about. They will reach out to Flexitouch in the process of creating a segment for the news. First of all I cant drive, and second I have to pay a $60 copay every time I go. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. /S /Transparency Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. For general information, Learn About Clinical Studies. /CropBox [0 0 612 792] /Length 585 Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational 7 0 obj 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 .