Has anyone else had any experience with this? /Filter /FlateDecode endobj They are in contact with patients who could benefit from a pneumatic pump. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. Im a pianist and its become my safe place. The woman from Idaho said her arm was softer and found the machine easy to use. First of all I cant drive, and second I have to pay a $60 copay every time I go. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. Venous Ulcers. Ive always been diligent about caring for my lymphedema but if there was a product that could further the health of my left arm, I was going to investigate. phone: +1 (623) 738-9011 (57) Webstore 3. https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. >> >> View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. I cannot find any shoes that fit my feet or any pants that fit comfortably . !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Resources << Subject Quality of Life will be assessed using EORTC C30 questionnaire. /Tabs /S << Breast cancer and treatment in itself was an awful journey. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Study record managers: refer to the Data Element Definitions if submitting registration or results information. If anyone has one, or knows of one, please contact me. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. /Pages 2 0 R >> 8 0 obj 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) 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. /C2_0 38 0 R 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. My lymphedema therapist also told me that the pumps werent worth it. 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 << Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. (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. 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. endobj /TT3 72 0 R YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! 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. It was up to me to piece it together. My go to place when I need calming. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /Type /Pages Negative value shows a increase in quality of life. 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. /Type /Action Its something Im passionate about. The pump has helped you achieve significant results. /Rect [40.95 36 85.101 45.216] Support Care Cancer (2020). /Resources << HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Group << The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. /Length 450 endstream XJ Heart failure (acute pulmonary edema, decompensated acute heart failure) [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. Yay! 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. 0 T Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Positive value shows an increase in Function/Range of Motion. Choosing to participate in a study is an important personal decision. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Most significantly was the reduction in my forearm. /S /Transparency /Length 412 ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN /CropBox [0.0 0.0 612.0 792.0] Swelling will be assessed using the ALOHA measurement protocol. 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. /TT0 22 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. JAMA Dermatol. /Subtype /Link /Tabs /S 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. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. 2. 35 0 R] All subjects will receive a single intervention. /Tabs /S k /Im0 24 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 18 0 obj The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. where is the compassion for ill people that NEED certain healthcare to get better? >> /TT1 50 0 R Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. 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. endobj >> /MediaBox [0.0 0.0 612.0 792.0] {%AIqEWRA>, Information provided by (Responsible Party): The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. /Rotate 0 The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Managing my lymphedema requires attention and an assortment of tools. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Negative value shows a decrease in swelling. What is encouraging is that you have had success with managing your lymphedema! /StructParents 0 I wonder if pumps can be reprogrammed. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Phone: 1.612.355.5100 Tens of thousands of. /Rotate 0 I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. Faced with negative publicity, they often end up making things right. Im sorry for the experience you had with Tactile Medical. /TT1 70 0 R The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Explain the situation to them. Keep in touch! Pembrolizumab plus cetuximab in patients with recurrent . So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. >> Adams, KE, Rasmussen JC, Darne C, et al. Lymphat Res Biol, 2016. /CropBox [0.0 0.0 612.0 792.0] One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. >> Talk with your doctor and family members or friends about deciding to join a study. /Subtype /Link << 11 0 obj 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. /CropBox [0 0 612 792] /BS << 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. /Rect [40.95 36 85.101 45.216] Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Biomedical Optics Express. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /TT3 74 0 R 3 0 obj !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /Rotate 0 HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5.