flexitouch plus head and neck flexitouch plus head and neck

>> /ExtGState << /C2_0 38 0 R Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Talk with your doctor and family members or friends about deciding to join a study. 0 T 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. << /StructParents 0 /StructParents 8 /Contents 75 0 R It delivers a noninvasive therapy that patients can administer themselves at home. >> 1. /Type /Page 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. Pembrolizumab plus cetuximab in patients with recurrent . You have reached the maximum number of saved studies (100). /Rotate 0 /Font << 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. They use them in the morning, at nightand feel very lucky.. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? /CropBox [0 0 612 792] /Annots [39 0 R] Adams, KE, Rasmussen JC, Darne C, et al. 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. 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/. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . I need help but theres a no return policy. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. History of the Northwest Lymphedema Center. /Rect [40.95 36 85.101 45.216] /Parent 2 0 R H]O0+=) ES D/N500187-000-00 Rev. >> Listing a study does not mean it has been evaluated by the U.S. Federal Government. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. They are usually called something like 7 on your side or Channel 3 helps you. /TT3 52 0 R See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 The head & neck of non-human animals - | Cambridge SMART Vocabulary Ive had my Flexitouch for almost five months. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). Faced with negative publicity, they often end up making things right. To pump or not to pumpthat is a question that I hear in the lymphedema community. It delivers a noninvasive therapy that patients can administer themselves at home. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. It takes just 32 minutes per day. << 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. /TT1 70 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /TT2 71 0 R 4. Ml6(|a\!A.;Q#[. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. It delivers a noninvasive therapy that patients can administer themselves at home. My insurance paid for all of it and the Tactile rep will help you get that. /ProcSet [/PDF /Text] /Type /Page ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. It takes just 32 minutes per day. I use it every evening. Search. Thank you for sharing and being an advocate for lymphedema! 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. 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 just finished 6 weeks of radiation. k 10 0 obj 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. Try contacting different people. 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. Numerous clinical studies show achievement of major clinical benefits and cost savings 2008-2023 HMP Global, Inc. All rights reserved. x Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. My interest in pumps suddenly skyrocketed! Support Care Cancer (2020). Choosing to participate in a study is an important personal decision. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Heart failure (acute pulmonary edema, decompensated acute heart failure) In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. /F 4 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. stream Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? {%AIqEWRA>, Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Thanks. /Font << This is not anadvertisement for Flexitouch.). Out of my sleeve, my 3/4 length sleeves arent as tight. >> /W 0 >> /TT0 69 0 R Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. /Subtype /Link 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. << 17 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. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /Resources << 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. /Tabs /S My lymphedema therapist also told me that the pumps werent worth it. >> Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 2010; Vol. Please write back in a month or so and let us know your progress. /Length 680 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. /C2_0 21 0 R Required fields are marked *. All subjects will receive a single intervention. >> In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. endobj XJ 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. /TT2 74 0 R Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Thumbs up for Flexi-Touch!! endobj /TT1 50 0 R where is the compassion for ill people that NEED certain healthcare to get better? Swelling will be assessed using the ALOHA measurement protocol. 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. 6 0 obj /CropBox [0.0 0.0 612.0 792.0] 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.. For more information, https://tactilemedical.com/about-us/. /TT3 74 0 R /Parent 2 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /StructParents 0 /Count 7 I have skipped 1 or 2 days just 3 or 4 times since March. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Support Care Cancer (, 2020). Overview Product Features Details Benefits /Contents 73 0 R The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Its been tough . 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.. endstream The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. 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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. endobj Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ 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. I always start with the one hour full arm and core setting. >> /Font << An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /Rotate 0 2016;14(4):198205. It was a blow to the life I had that I once had. Subject Quality of Life will be assessed using EORTC C30 questionnaire. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. Words like new kind of pump, different than the old types, favorable studies, and Dr. Sign up today for your free Reader Account. Percentage of each response captured. Free shipping for many products! 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. Chronic Wounds 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. (Note: There are other well regarded pumps on the market. /Rect [40.95 36 85.101 45.216] Choosing to participate in a study is an important personal decision. /Group << 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. Talk with your doctor and family members or friends about deciding to join a study. Hope it works out. 3. 1 0 obj Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /Pages 2 0 R I have been having weekly physical therapy to help with lymphedema and range of motion issues. /Type /Group 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. endstream Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). I did a baseline measurement of my left arm before treatment and three weeks after using the pump. /TT3 59 0 R 3 0 obj To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. I can relate all too well to what you have been through. She explained that compression pumps force air into sleeves with multiple chambers. endstream /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) | Source: Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /C2_0 54 0 R Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. /StructParents 7 About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Numerous garment and program options to meet each patient's unique treatment needs Most significantly was the reduction in my forearm. 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. /Subtype /Link << /CS /DeviceRGB When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. /TT2 72 0 R /CS /DeviceRGB /Resources << Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /F 4 Your email address will not be published. My husband?s pump system arrived yesterday. PW!\v(jfz:yX 8$W"wqHbxQDL /Type /Page If you still have the system, I am interested. 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. << I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. The woman from Idaho said her arm was softer and found the machine easy to use. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. My therapist said they cannot be reused by another. >> Hi Deborah, How wonderful you have had such positive success with your pump. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Any circumstance where increased lymphatic or venous return is undesirable /BS << S Study record managers: refer to the Data Element Definitions if submitting registration or results information. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 5 0 obj /BS << UGH! stream >> /Im0 24 0 R Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. << /Length 498 Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. 3701 Wayzata Blvd, Suite 300 /Rotate 0 >> So we appealed 3 times. Support Care Cancer (2020). Ideas? Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Thanks. 14 0 obj 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. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. >> /TT1 57 0 R /A << 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 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. 2. 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 . 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).