6 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. Ml6(|a\!A.;Q#[. /Annots [39 0 R] /TT1 70 0 R Negative value shows a decrease in pain. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. It takes just 32 minutes per day. Percentage of each response captured. /Tabs /S We rely on the generosity of individuals and sponsors who support our mission and activities. Why Should I Register and Submit Results? Support Care Cancer (, 2020). ? https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. /Filter /FlateDecode Free shipping for many products! >> >> Buying a reconditioned machine saved me some money. /Parent 2 0 R Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Oral Oncology. Type of Use (Select one or both, as applicable) lXI . I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 1. << 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. endobj Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Developing Lymphedema and not being able to get the help that I neededwas awful. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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 . I had a mastectomy and 9 lymph nodes removed 3 months ago. Michelin Man came to mind as I stretched out on the couch. All reviewers. /TT0 49 0 R The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. The Flexitouch Plus 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. Hi Jaime, Im hopeful that your new pump will provide relief. It delivers a noninvasive therapy that patients can administer themselves at home. Swelling will be assessed using the ALOHA measurement protocol. Its New, Your email address will not be published. /TT2 72 0 R Thank you for writing. k >> Dr. Shelia Ridner Dr. Barbara Murphy Deng J, et al. 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. Both Ease of Use/Satisfaction will be assessed by survey. Out of my sleeve, my 3/4 length sleeves arent as tight. I have little confidence that the FaceTime call offered will be of much use. 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. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Phone: 1.612.355.5100 A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. September 30, 2021 09:03 ET /TT0 56 0 R I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. The woman from Idaho said her arm was softer and found the machine easy to use. /Resources << 4. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. /C2_0 48 0 R Overview Product Features Details Benefits Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). 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. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional 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. It has become so bad that I can barely walk. Support Care Cancer (2020). /Rotate 0 Many head and neck cancer survivors are faced with an additional challenge: lymphedema. D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, 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/. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. 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. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. Please remove one or more studies before adding more. /W 0 Hi Wally, Hope someone is able to meet your request. Hi Kristie, Thank you for sharing your story. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. 3701 Wayzata Blvd, Suite 300 It delivers a noninvasive therapy that patients can administer themselves at home. /C2_0 38 0 R As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. The warranty was the same as a new machine. 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.. /CropBox [0.0 0.0 612.0 792.0] He just never could get use to using it and being able to don the garments. /Parent 2 0 R /MediaBox [0.0 0.0 612.0 792.0] The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. >> Subject Quality of Life will be assessed using EORTC C30 questionnaire. I use it everyday for an hour. I am looking for a left arm garment for the flexitouch plus. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Talk with your doctor and family members or friends about deciding to join a study. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Tabs /S I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. /Length 498 /Font << stream She explained that compression pumps force air into sleeves with multiple chambers. Hi Kathi, The FaceTime call might work! Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 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. [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. phone: +1 (623) 738-9011 (57) Webstore 3. /TT1 70 0 R << endstream 12 0 obj Words like new kind of pump, different than the old types, favorable studies, and Dr. /Rotate 0 /TT1 57 0 R /Resources << 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. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /Font << /StructParents 6 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. << Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) >> /Annots [10 0 R 11 0 R 12 0 R] Then I got my flexitouch and my life changed. Lymphat Res Biol. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. I know many others can as well. endobj Chronic Wounds << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. /CS /DeviceRGB /MediaBox [0 0 612 792] /Im0 60 0 R << I have a uniboot compressions on both of my calves. The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. Managing my lymphedema requires attention and an assortment of tools. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. When I called my surgeon, he recommended that I not use the FlexiTouch on my chest because the compression can make the tissue expander rupture. I did send them an email and asked them to look at your case again.
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