Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Rz:MzI6 I didnt need a lymphedema physical therapist but too much to explain here. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Lymphat Res Biol, 2016. HTo0~G6)BjH7u 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. My husband has a brand new system that Im trying to sell. 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. 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 . S 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. The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Ridner, S.H., Dietrich, M.S., Deng, J. et al. Phone: 1.612.355.5100 /MediaBox [0 0 612 792] The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp (Note: There are other well regarded pumps on the market. Upper set (head and neck). My go to place when I need calming. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 3701 Wayzata Blvd, Suite 300 I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. 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. 13 0 obj >> Heart failure (acute pulmonary edema, decompensated acute heart failure) /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R All subjects will receive a single intervention. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. 2013; Vol. 6 0 obj If you still have the system, I am interested. Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. My Experience with the Flexitouch Pneumatic Pump for Lymphedema Lymphedema - Head and Neck Cancer Alliance >> https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment 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 use it every evening. /Length 680 /Type /Page I dont know if it will make a difference. Ml6(|a\!A.;Q#[. I would contact your local news station that has a consumer investigation/help line. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 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) . Any circumstance where increased lymphatic or venous return is undesirable 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. endstream stream A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. It delivers a noninvasive therapy that patients can administer themselves at home. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. >> Its been tough . Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Flexitouch Pd32-u Lymphedema Treatment System Pump /Filter /FlateDecode The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. /Group << 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 << /F 4 Subject overall health and quality of life in the past week-EORTC C30. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. It has made my life miserable. >> (6Kjw_XGz'g &p 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. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. << First of all I cant drive, and second I have to pay a $60 copay every time I go. /TT2 71 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. The Head & Neck Program is just 32 minutes long. The warranty was the same as a new machine. /Font << >> I decided to purchase one without insurance. Flexitouch Pd32-u Lymphedema Treatment System Pump >> Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational << Advanced pneumatic compression for treatment of lymphedema of the head My therapist said they cannot be reused by another. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. endobj The pump is awesome works for me iam walking better @ standing the swelling goes away!!! The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /S /URI Type of Use (Select one or both, as applicable) lXI . Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? >> /F 4 O ce they are used the government wont always them to use them on another. Actually they dont know much about lymphedema. I have skipped 1 or 2 days just 3 or 4 times since March. >> My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Yes. 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. Write a review. It delivers a noninvasive therapy that patients can administer themselves at home. /S /URI 11 0 obj >> 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. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /Contents 73 0 R 5. 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. Im a pianist and its become my safe place. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. I am looking for a left arm garment for the flexitouch plus. Lymphat Res Biol. Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or 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 just received the flexitouch plus, but I think the leg garments are too big. Yay! 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). Flexitouch Pd32-u Lymphedema Treatment System Pump. Your email address will not be published. Percentage of each response captured. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. /Filter /FlateDecode 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. 14 0 obj If Im out late, I use it in the morning and then resume again in the evening. endstream Head and Neck Cancer Lymphedema - Tactile Medical >> /Type /Group Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. /StructParents 6 PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and /URI (http://www.fda.gov/) As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? 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. For general information, Learn About Clinical Studies. If anyone has one, or knows of one, please contact me. /Rotate 0 Lymphat Res Biol. 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. 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.. Free shipping for many products! 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 /Catalog The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. A healthy lymphatic system moves lymph fluid throughout the body. /Tabs /S I can relate all too well to what you have been through. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. 17 0 obj The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). Its amazing to me how little doctors know about lymphedema. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Negative value shows a increase in quality of life. I have little confidence that the FaceTime call offered will be of much use. /StructParents 0 Top reviews. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. We were asked to improve the ease of donning . 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