/Annots [10 0 R 11 0 R 12 0 R] /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) 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. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Support Care Cancer (2020). Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 2. My go to place when I need calming. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. 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^ endobj >> /MediaBox [0 0 612 792] Looking at his ankles there IS no swelling now. I dont know if it will make a difference. Any circumstance where increased lymphatic or venous return is undesirable HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 14(4): p. 198-205. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /ProcSet [/PDF /Text] I always start with the one hour full arm and core setting. 2013; Vol. endstream /A << Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 Rz:MzI6 Positive value shows an increase in swelling. /S /Transparency /Tabs /S Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. The lymphedema seen in patients treated for head . >> Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time /Contents 53 0 R 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. 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. << (Clinical Trial). /C2_1 55 0 R Its amazing how we are communicating so much more through technology because of Covid. 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. Thank you for writing. It delivers a noninvasive therapy that patients can administer themselves at home. /StructParents 2 Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Percentage of each response captured. Do you know of anyone whom would want to buy it? /Count 7 Explain the situation to them. Negative value shows a decrease in quality of life/overall health. 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. /CS /DeviceRGB Then I got my flexitouch and my life changed. S YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! /Annots [39 0 R] https://doi.org/10.1007/s00520-020-05540-8, 3. 2. /ProcSet [/PDF /Text /ImageC] Thanks. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. /CS /DeviceRGB /URI (http://www.fda.gov/) 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 Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. D/N500187-000-00 Rev. /TT2 51 0 R 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. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. 3701 Wayzata Blvd, Suite 300 Dr. Shelia Ridner Dr. Barbara Murphy ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. A healthy lymphatic system moves lymph fluid throughout the body. UGH! Ml6(|a\!A.;Q#[. >> 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. (Note: There are other well regarded pumps on the market. endobj 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. Its amazing to me how little doctors know about lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. /C2_0 21 0 R 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. My husband has a brand new system that Im trying to sell. 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. Thumbs up for Flexi-Touch!! 4 0 obj Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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. /CropBox [0 0 612 792] I cant explain that but I can visually see a difference. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . /Filter /FlateDecode 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. /Parent 2 0 R Please remove one or more studies before adding more. /XObject << In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 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. stream I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. I would suggest you keep contacting Tactile Medical. 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. Numerous clinical studies show achievement of major clinical benefits and cost savings +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP . 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. endobj I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. I decided to purchase one without insurance. >> >> The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. >> Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. The content is not intended to substitute manufacturer instructions. 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 . /Type /Catalog Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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! Lymphat Res Biol, 2016. Numerous garment and program options to meet each patient's unique treatment needs 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. Positive value shows an increase in Function/Range of Motion. endobj Study record managers: refer to the Data Element Definitions if submitting registration or results information. Its been tough . /Rotate 0 Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /Length 498 !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. >> /Font << I really need this system and had such desperate hope. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). To pump or not to pumpthat is a question that I hear in the lymphedema community. /Rect [40.95 36 85.101 45.216] /Resources << 15 0 obj /CropBox [0.0 0.0 612.0 792.0] What really gripes me is that my nurse practitioner wouldnt even consider ordering one. 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. >> Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. Both Ease of Use/Satisfaction will be assessed by survey. 18 0 obj /Type /Pages Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 1. Tens of thousands of. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. /URI (http://www.fda.gov/) /Filter /FlateDecode did you sell it yet? Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. 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/. /Subtype /Link 3 0 obj << Out of my sleeve, my 3/4 length sleeves arent as tight. Negative value shows a decrease in Function/Range of Motion. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Michelin Man came to mind as I stretched out on the couch. << Percent change is calculated by the difference between scores averaged at 6 months versus baseline. [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. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. 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. /Resources << For more information, https://tactilemedical.com/about-us/. >> What is encouraging is that you have had success with managing your lymphedema! >> Listing a study does not mean it has been evaluated by the U.S. Federal Government. The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. 5 0 obj Hi Kathi, The FaceTime call might work! I used it a few times and Im good now. Lymphat Res Biol. My insurance company required me to use a different brand of compression pump and experience failure before they would consider covering the cost of a Flexitouch. My insurance paid for all of it and the Tactile rep will help you get that. 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 It was a blow to the life I had that I once had. Material and methods Design and participants 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. /Type /Page And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Developing Lymphedema and not being able to get the help that I neededwas awful. /Pages 2 0 R I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. 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.