>> /StructParent 1 Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials 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. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /ExtGState << /Length 450 Advanced Techniques in Canine and Feline Neurosurgery 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. . k 2015 51 (431-437), 1. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. /Rotate 0 /Parent 2 0 R I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. . They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. Talk with your doctor and family members or friends about deciding to join a study. where is the compassion for ill people that NEED certain healthcare to get better? Both Ease of Use/Satisfaction will be assessed by survey. /TT0 49 0 R /StructParents 2 << /C2_0 54 0 R During pregnancy (applies only to the Flexitouch Plus trunk accessory). /Rotate 0 Its something Im passionate about. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. | Source:
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. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. << Flexitouch . /CS /DeviceRGB A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. /Tabs /S Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. Faced with negative publicity, they often end up making things right. Lymphedema Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /S /URI At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. /Parent 2 0 R Call us at 1.833.3TACTILE (1-833-382-2845), 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. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Hi Jaime, Im hopeful that your new pump will provide relief. 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. /Filter /FlateDecode He just never could get use to using it and being able to don the garments. << << 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. /Length 585 >> My husband has a brand new system that Im trying to sell. In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. 4 0 obj 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. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. 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) When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /Subtype /Link /CropBox [0 0 612 792] 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. /Type /Page In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. I have been suffering from lymphedema for the past 2 years. Hope it works out. Since using the Flexitouch for almost a year, she had not experienced cellulitis. /TT3 74 0 R /BS << endstream 1 0 obj Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Advanced pneumatic compression for treatment of lymphedema of the head Flexitouch Pd32-u Lymphedema Treatment System Pump. 8 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. We rely on the generosity of individuals and sponsors who support our mission and activities. >> /StructParents 0 S Search. /Type /Action Type of Use (Select one or both, as applicable) lXI . /MediaBox [0.0 0.0 612.0 792.0] What is encouraging is that you have had success with managing your lymphedema! /Rect [40.95 36 85.101 45.216] 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/. Its my new normal and Im thankful!! One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Yes. Swelling will be assessed using the ALOHA measurement protocol. HTo0~G6)BjH7u It has become so bad that I can barely walk. It delivers a noninvasive therapy that patients can administer themselves at home.
Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /BS << Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. The pump has helped you achieve significant results. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Last updated March 2021. 17 0 obj Many head and neck cancer survivors are faced with an additional challenge: lymphedema. 1. /Rect [90.257 252.64 421.33 266.44] It delivers a noninvasive therapy that patients can administer themselves at home. Pain will be assessed using the VAS Pain Scale. My therapist said they cannot be reused by another. The woman from Idaho said her arm was softer and found the machine easy to use. It delivers a noninvasive therapy that patients can administer themselves at home. Why Should I Register and Submit Results? I have it in both of my legs mostly in my thighs. 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. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /Im0 60 0 R Flexitouch Plus - Treat Head & Neck Swelling At Home with This Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! Venous Ulcers. /TT3 52 0 R Minneapolis, MN 55416 USA The head & neck of non-human animals - Any circumstance where increased lymphatic or venous return is undesirable The whole process, though limiting my ambulation, was comfortable and relaxing. * American Society of Clinical Oncology 1. endobj /Annots [10 0 R 11 0 R 12 0 R] Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. >> /C2_1 55 0 R The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. /Tabs /S /Type /Action /TT1 70 0 R My interest in pumps suddenly skyrocketed! Hopefully it will give me a better quality of life because I dont know what else to do at this point. I greatly encourage others to try to obtain one if they are able and if it is a good option for them. >> >> << /TT0 69 0 R Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /Subtype /Link I have a pump system left and right leg also stomach wraps. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. 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.. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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. /TT0 69 0 R 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. I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. I dont like that I have to do it but it has changed my legs back to normal. /Tabs /S UGH! /W 0 Negative value shows a increase in quality of life. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. /TT0 69 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. Flexitouch Plus - Tactile Medical If Im out late, I use it in the morning and then resume again in the evening. /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] How customer reviews and ratings work See All Buying Options. /Parent 2 0 R Flexitouch Pd32-u Lymphedema Treatment System Pump /MediaBox [0 0 612 792] Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. Keep in touch! << Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 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 wanted to talk to some people who had actually used the pump. /TT0 56 0 R >> September 30, 2021 09:03 ET
18 0 obj You have reached the maximum number of saved studies (100). & weigh 126 lbs. /CS /DeviceRGB Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Positive value shows an increase in swelling. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. /C2_0 38 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /Filter /FlateDecode phone: +1 (623) 738-9011 (57) Webstore 3. /MediaBox [0 0 612 792] stream
>> 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. /A << endobj stream
? /Count 7 Flexitouch Plus - Applying the Head and Neck Garment Set 2016;14(4):198205. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /Contents 36 0 R 35 0 R] Deng J, et al. 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! Free shipping for many products! Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. did you sell it yet? I would be interested to hear how your husbands experience with his new pump. Negative value shows a decrease in symptoms/problems. /S /Transparency >> /TT1 70 0 R 3 0 obj 1(1): 114125. Minneapolis, MN 55416 USA 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. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) You are benefiting the lymphedema community. So we appealed 3 times. /C2_0 48 0 R I used it a few times and Im good now. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. 16 0 obj 13 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. Numerous clinical studies show achievement of major clinical benefits and cost savings This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. It was a blow to the life I had that I once had. Hi Wally, Hope someone is able to meet your request. 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. I didnt need a lymphedema physical therapist but too much to explain here. 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. Explain the situation to them. 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/. Most significantly was the reduction in my forearm. 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. /Type /Catalog I was told purchased high priced left garments which I dont think I needed. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Hi Kathi, The FaceTime call might work! I cant explain that but I can visually see a difference. /URI (http://www.fda.gov/) My go to place when I need calming. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am?
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