Thank you for writing. 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/. Write a review. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> stream XJ /Type /Page /Resources << /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] Listing a study does not mean it has been evaluated by the U.S. Federal Government. stream /Length 412 stream In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. My therapist said they cannot be reused by another. 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. Heart failure (acute pulmonary edema, decompensated acute heart failure) >> Filter by. Study record managers: refer to the Data Element Definitions if submitting registration or results information. It delivers a noninvasive therapy that patients can administer themselves at home. /A << View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, 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. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. Phone: 1.612.355.5100 endstream /Type /Page I was told purchased high priced left garments which I dont think I needed. Pain will be assessed using the VAS Pain Scale. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. My thighs are so big that I can no longer Drive. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 Study record managers: refer to the Data Element Definitions if submitting registration or results information. So we appealed 3 times. /Length 450 /TT2 58 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. 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^ /Subtype /Link It has made my life miserable. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Negative value shows a decrease in quality of life/overall health. 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! When I first went to physical therapy, she was running through some more common contibuters to swelling. /TT3 74 0 R 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. /URI (http://www.fda.gov/) 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. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. The whole process, though limiting my ambulation, was comfortable and relaxing. Why Should I Register and Submit Results? There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Please remove one or more studies before adding more. /ProcSet [/PDF /Text /ImageC] Material and methods Design and participants /XObject << Its brand new, used 1 time. 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). They are in contact with patients who could benefit from a pneumatic pump. Lymphedema 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. 2015;151(11):11871193. /BS << Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /XObject << 2008-2023 HMP Global, Inc. All rights reserved. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Im only 44 years old , and I have kids that need mom back. The pump has helped you achieve significant results. >> /StructParents 6 Numerous garment and program options to meet each patient's unique treatment needs Choosing to participate in a study is an important personal decision. /Tabs /S https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. /Rect [90.257 252.64 421.33 266.44] Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. I?m 5? A healthy lymphatic system moves lymph fluid throughout the body. [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. 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 go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Breast cancer and treatment in itself was an awful journey. eIb? HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /MediaBox [0 0 612 792] /Tabs /S You have reached the maximum number of saved studies (100). endstream << (Note: There are other well regarded pumps on the market. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /CropBox [0.0 0.0 612.0 792.0] Chronic Wounds document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Rotate 0 Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. 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. /StructParents 7 >> /Resources << O ce they are used the government wont always them to use them on another. endobj endobj /C2_0 48 0 R My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. 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. 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. PW!\v(jfz:yX 8$W"wqHbxQDL Ridner, S.H., Dietrich, M.S., Deng, J. et al. {%AIqEWRA>, I just finished 6 weeks of radiation. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 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. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Last updated March 2021. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. All reviewers. 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. 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. /StructParent 1 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 8 0 obj /Type /Pages 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 I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /Subtype /Link >> does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Faced with negative publicity, they often end up making things right. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 46(4): 480487. /StructParents 0 I chatted with a woman from Tacoma and another from Idaho. Subject overall health and quality of life in the past week-EORTC C30. Ridner, S.H., Dietrich, M.S., Deng, J. et al. D/N500187-000-00 Rev. /CropBox [0 0 612 792] endobj Developing Lymphedema and not being able to get the help that I neededwas awful. /Parent 2 0 R Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational I did send them an email and asked them to look at your case again. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. Try contacting different people. /Resources << /Filter /FlateDecode For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. 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! Minneapolis, MN 55416 USA Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Its my new normal and Im thankful!! Can I use the machine on lower limbs with compression garments above? The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /W 0 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) /Group << 10 0 obj A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Minneapolis, MN 55416 USA Learn how your comment data is processed. During pregnancy (applies only to the Flexitouch Plus trunk accessory). 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. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. The lymphedema seen in patients treated for head . /Contents 75 0 R 0 T Hi Kathi, The FaceTime call might work! /A << endobj Toll-free: 1.833.3TACTILE (1.833.382.2845) . I always start with the one hour full arm and core setting. >> >> Ideas? If anyone has one, or knows of one, please contact me. It delivers a noninvasive therapy that patients can administer themselves at home. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. << The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 2 0 obj >> 11 0 obj 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 . NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( >> Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. My best to you. Yes. /Font << /Font << Since using the Flexitouch for almost a year, she had not experienced cellulitis. It takes just 32 minutes per day. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. Learn More Take the steps now to help your head and neck cancer survivors. /Resources << HQK0)I46IC">bY3oons} K.4V./`\f0 Fs 3701 Wayzata Blvd, Suite 300 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. 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 use it every evening. I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. /TT1 70 0 R Free shipping for many products! Lymphat Res Biol, 2016. 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. (6Kjw_XGz'g &p << I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. 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. /Rect [40.95 36 85.101 45.216] /CropBox [0.0 0.0 612.0 792.0] Support Care Cancer (2020). /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) You have reached the maximum number of saved studies (100). 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. She explained that compression pumps force air into sleeves with multiple chambers. 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. /TT2 51 0 R /Font << Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Biomedical Optics Express. /Parent 2 0 R An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Two years on pump controller and garments. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Rotate 0 Hi Deborah, How wonderful you have had such positive success with your pump. /F 4 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 delivers a noninvasive therapy that patients can administer themselves at home. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /GS0 37 0 R Karaca-Mandic P, Hirsch AT, Rockson SG, et al. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. Phone: 1.612.355.5100 Negative value shows a increase in quality of life. 17 0 obj Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. phone: +1 (623) 738-9011 (57) Webstore 3. Thumbs up for Flexi-Touch!! The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. 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. 2. 14(4): p. 198-205, 2. Your email address will not be published. 14(4): p. 198-205. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /TT0 56 0 R >> One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /S /URI I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. We were asked to improve the ease of donning . x 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. >> September 30, 2021 09:03 ET https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. >> Another set of pads enveloped my left thigh and trunk. 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. Sort by. /Length 470 The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. 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.