If Im out late, I use it in the morning and then resume again in the evening. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational 7 0 obj /Type /Group I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. 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. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. When I first went to physical therapy, she was running through some more common contibuters to swelling. My skin appears more like the skin on my right arm. Search. endobj }3eIH]^p~>_ y#h`*#OPQB_lVI"p! When she said piano I froze. 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. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /TT1 50 0 R /Subtype /Link >> /Contents 53 0 R Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Hi Kristie, Thank you for sharing your story. Oral Oncology. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. 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. Positive value shows an increase in swelling. /Rect [90.257 252.64 421.33 266.44] /StructParents 0 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /TT0 22 0 R Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. % 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. 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. << I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. /ProcSet [/PDF /Text] /S /Transparency Hi Karyn, I will post your comment and see if Sarah still has the pump available. 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. I really need this system and had such desperate hope. endobj 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. /Rotate 0 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^ 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. /StructParents 7 Type of Use (Select one or both, as applicable) lXI . I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. It was a blow to the life I had that I once had. Filter by. I have lymphedema in my right arm, breast and axilla. /Contents 75 0 R Adams, KE, Rasmussen JC, Darne C, et al. Phone: 1.612.355.5100 The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. I?m 5? Study record managers: refer to the Data Element Definitions if submitting registration or results information. Minneapolis, MN 55416 USA Words like new kind of pump, different than the old types, favorable studies, and Dr. Positive value shows an decrease in quality of life. (Clinical Trial). I like to joke, Honey, time for me to put the squeeze on you /CropBox [0 0 612 792] >> k /Type /Catalog Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. (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. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. 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. did you sell it yet? /TT2 72 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. Its also a relief not to manually MLD my arm every night. endobj Flexitouch Pd32-u Lymphedema Treatment System Pump. /TT0 69 0 R Ideas? He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. 2015;151(11):11871193. Its New, Your email address will not be published. << /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] endobj The leg garments that I received are for a much taller person. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Sort by. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. I am looking for a left arm garment for the flexitouch plus. /A << This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. 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. 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. >> Tens of thousands of. /Tabs /S /Group << {%AIqEWRA>, Most significantly was the reduction in my forearm. /Resources << I cant explain that but I can visually see a difference. Choosing to participate in a study is an important personal decision. 4? 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. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. where is the compassion for ill people that NEED certain healthcare to get better? endobj Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Lymphat Res Biol, 2016. 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.. This is not anadvertisement for Flexitouch.). 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. >> I greatly encourage others to try to obtain one if they are able and if it is a good option for them. 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. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use I have skipped 1 or 2 days just 3 or 4 times since March. 3701 Wayzata Blvd, Suite 300 View this study on Beta.ClinicalTrials.gov, 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. /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] 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. 10 0 obj Positive value shows an increase in pain. 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.. Talk with your doctor and family members or friends about deciding to join a study. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /StructParent 1

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