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. /Length 680 You are benefiting the lymphedema community. /Subtype /Link Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. >> Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 7 0 obj endobj /Type /Page 17 0 obj between head and neck cancer and lymphedema. Flexitouch Plus Lymphedema Treatment of the Head and Neck I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. Support Care Cancer (2020).
(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. 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 Medical Device Innovation | Nottingham Spirk Design Collaborative 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/. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Lymphat Res Biol. /Im0 60 0 R !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. You have reached the maximum number of saved studies (100). Ml6(|a\!A.;Q#[. /Rotate 0 /Group << To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Tactile Systems Technology, Inc. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. % 4. >> bic)xPt%Iss>2N'1`G
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Reading or watching TV are the activities Im able to do while Im being treated. /StructParent 1 Sort by. For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Our Solutions for Head and Neck - Tactile Medical Thank you for writing. << Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN >> Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Any circumstance where increased lymphatic or venous return is undesirable 7nwJ@6]?t~.} /MediaBox [0 0 612 792] 2. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /StructParents 0 endstream I really need this system and had such desperate hope. x
HQK0)I46IC">bY3oons} K.4V./`\f0 Fs >> Its New, Your email address will not be published. /CropBox [0.0 0.0 612.0 792.0] The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes.
/CS /DeviceRGB Upper set (head and neck). /CS /DeviceRGB >> I can relate all too well to what you have been through. Hi Wally, Hope someone is able to meet your request. /CropBox [0 0 612 792] Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. Managing my lymphedema requires attention and an assortment of tools. I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Can I use the machine on lower limbs with compression garments above? The content is not intended to substitute manufacturer instructions. 3701 Wayzata Blvd, Suite 300 Positive value shows an increase in Function/Range of Motion. (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. /Subtype /Link /TT0 56 0 R /Font << Subject overall health and quality of life in the past week-EORTC C30. Its amazing to me how little doctors know about lymphedema. The whole process, though limiting my ambulation, was comfortable and relaxing. /Tabs /S /Parent 2 0 R Actually they dont know much about lymphedema. 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. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . The warranty was the same as a new machine. I just received it yesterday and Im super hopeful that it will help. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. endobj Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency The Flexitouch Plus system should not be used on patients with one or more of the following conditions: I did send them an email and asked them to look at your case again. /Contents 36 0 R << Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /S /URI The head & neck of non-human animals - | Cambridge SMART Vocabulary /MediaBox [0.0 0.0 612.0 792.0] /TT1 57 0 R My go to place when I need calming. {%AIqEWRA>, >> endobj And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. /XObject << I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Breast cancer and treatment in itself was an awful journey. endobj /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] Please write back in a month or so and let us know your progress. << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Thank you for sharing and being an advocate for lymphedema! Listing a study does not mean it has been evaluated by the U.S. Federal Government. stream
Tactile Systems Technology, Inc.
Material and methods Design and participants D/N500187-000-00 Rev. What is encouraging is that you have had success with managing your lymphedema! /Type /Page 3 total ratings, 2 with reviews There was a problem filtering reviews right now. /StructParents 0 Type of Use (Select one or both, as applicable) lXI . Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 2010; Vol. /Count 7 Daily storage of Flextouch system - Lymphedema - Inspire endobj 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. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /Group << Flexitouch Pd32-u Lymphedema Treatment System Pump The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. %PDF-1.4 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. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. endobj Free shipping for many products! /Parent 2 0 R [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. When she said piano I froze. Yay! Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /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] 10 0 obj About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. /CropBox [0.0 0.0 612.0 792.0] Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /S /URI << )XXAc21Z(VAP\+swqri#1
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f/]zR3N1D]-/A->byyo/4PMv Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Text, image, video. /Font << 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/. /MediaBox [0 0 612 792] I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. I have skipped 1 or 2 days just 3 or 4 times since March. Heart failure (acute pulmonary edema, decompensated acute heart failure) 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. EJVES. 3701 Wayzata Blvd, Suite 300 Advanced pneumatic compression for treatment of lymphedema of the head /A << I have little confidence that the FaceTime call offered will be of much use. >> 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. 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) . I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. >> /W 0 Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or 3 0 obj Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /TT2 72 0 R 6 0 obj /ProcSet [/PDF /Text] /CropBox [0 0 612 792] Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Choosing to participate in a study is an important personal decision. /Length 585 Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). For more information, https://tactilemedical.com/about-us/. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema.
+t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. /Rotate 0 She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Hi Deborah, How wonderful you have had such positive success with your pump.
I use it everyday for an hour. /Length 498 Study record managers: refer to the Data Element Definitions if submitting registration or results information. endstream /Type /Group 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. 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. 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. /Rect [40.95 36 85.101 45.216] Please remove one or more studies before adding more. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 2. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. The lymphedema seen in patients treated for head . Keep sharing your story. 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. This is not anadvertisement for Flexitouch.). /Length 412 A Pilot Study to Evaluate the Feasibility and Potential Effectiveness /MediaBox [0 0 612 792] Swelling will be assessed using the ALOHA measurement protocol. My lymphedema therapist also told me that the pumps werent worth it. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. 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. 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday, 3701 Wayzata Blvd, Suite 300 endobj endstream Pain will be assessed using the VAS Pain Scale. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. My best to you. Tens of thousands of. Ridner, S.H., Dietrich, M.S., Deng, J. et al. To pump or not to pumpthat is a question that I hear in the lymphedema community. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. You have reached the maximum number of saved studies (100). Has anyone else had any experience with this? 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.