Rockson floated to my ears. >> 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. % by Flexitouch. She explained that compression pumps force air into sleeves with multiple chambers. /MediaBox [0.0 0.0 612.0 792.0] https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 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. /Resources << I would suggest you keep contacting Tactile Medical. Venous Ulcers. /S /URI When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Its something Im passionate about. Text, image, video. /MediaBox [0.0 0.0 612.0 792.0] /TT1 57 0 R /TT2 72 0 R Support Care Cancer (, 2020). endobj [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. Last updated March 2021. endobj >> The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Top reviews. 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. x >> The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Free shipping for many products! Hi Jaime, Im hopeful that your new pump will provide relief. He just never could get use to using it and being able to don the garments. >> Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /CS /DeviceRGB endobj stream 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. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? /ProcSet [/PDF /Text] 15 0 obj between head and neck cancer and lymphedema. Swelling will be assessed using the ALOHA measurement protocol. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Dr. Shelia Ridner Dr. Barbara Murphy Pain will be assessed using the VAS Pain Scale. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 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. Flexitouch . >> Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ >> For more information, https://tactilemedical.com/about-us/. 2. /C2_0 38 0 R /Type /Group 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/. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 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. Ive had my Flexitouch for almost five months. endstream /Type /Group 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. I am looking for a left arm garment for the flexitouch plus. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. They use them in the morning, at nightand feel very lucky.. 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. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I have a uniboot compressions on both of my calves. /TT3 72 0 R >> Flexitouch Pd32-u Lymphedema Treatment System Pump. /A << What is encouraging is that you have had success with managing your lymphedema! Muluk SC, Hirsch AT, Tafe EC. My husband has a brand new system that Im trying to sell. /CropBox [0 0 612 792] Type of Use (Select one or both, as applicable) lXI . Has anyone else had any experience with this? 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. 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. 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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 the Flexitouch Plus device. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. 10 0 obj Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /ProcSet [/PDF /Text] /Annots [10 0 R 11 0 R 12 0 R] Its also a relief not to manually MLD my arm every night. If Im out late, I use it in the morning and then resume again in the evening. 7 0 obj 1. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. eIb? This is not anadvertisement for Flexitouch.). /Type /Action I wonder if pumps can be reprogrammed. I just received it yesterday and Im super hopeful that it will help. /StructParents 7 2 0 obj /Filter /FlateDecode /TT2 58 0 R 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. Its amazing to me how little doctors know about lymphedema. 14(4): p. 198-205. 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. I would be interested to hear how your husbands experience with his new pump. Yes. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. 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. endobj Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 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. /Resources << What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Negative value shows a decrease in pain. You have reached the maximum number of saved studies (100). << Learn how your comment data is processed. The pump is called the Flexitouch System by Tactile Medical. /Type /Group The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. >> September 30, 2021 09:03 ET K-ZB: The Head & Neck Program is just 32 minutes long. /Type /Action The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 6 0 obj Toll-free: 1.833.3TACTILE (1.833.382.2845) Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. Deng J, et al. Hopefully it will give me a better quality of life because I dont know what else to do at this point. /StructParents 2 Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /ProcSet [/PDF /Text /ImageC] Positive value shows an increase in quality of life/overall health. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. /TT3 52 0 R The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Learn More Take the steps now to help your head and neck cancer survivors. Negative value shows a increase in quality of life. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. EJVES. /XObject << 1(1): 114125. >> /Filter /FlateDecode /Pages 2 0 R 3701 Wayzata Blvd, Suite 300 Im only 44 years old , and I have kids that need mom back. It delivers a noninvasive therapy that patients can administer themselves at home. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Tabs /S * American Society of Clinical Oncology 1. /W 0 See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 I decided to purchase one without insurance. /S /Transparency PW!\v(jfz:yX 8$W"wqHbxQDL 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. My husband?s pump system arrived yesterday. Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. Rz:MzI6 >> HQK0)I46IC">bY3oons} K.4V./`\f0 Fs The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). 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. endobj They will reach out to Flexitouch in the process of creating a segment for the news. Sign up today for your free Reader Account. /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 See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use << >> << He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. 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. Tactile Systems Technology, Inc. I would contact your local news station that has a consumer investigation/help line. My interest in pumps suddenly skyrocketed! Lymphedema The head & neck of non-human animals - | Cambridge SMART Vocabulary 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. 4. I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. /Font << does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? /Group << 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). 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. /W 0 /CS /DeviceRGB Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. /StructParents 0 Listing a study does not mean it has been evaluated by the U.S. Federal Government. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? I?m 5? Flexitouch Plus provides flexible program options. Yay! ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN Write a review. Toll-free: 1.833.3TACTILE (1.833.382.2845) All reviewers. /CropBox [0 0 612 792] 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /Font << 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. 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. /ProcSet [/PDF /Text /ImageC] I use it everyday for an hour. Two years on pump controller and garments. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /MediaBox [0.0 0.0 612.0 792.0] Ridner, S.H., Dietrich, M.S., Deng, J. et al. It delivers a noninvasive therapy that patients can administer themselves at home. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. endstream Phone: 1.612.355.5100 Hi Wally, Hope someone is able to meet your request. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. I use it every evening. 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.. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) I used it a few times and Im good now. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. I have a pump system left and right leg also stomach wraps. Im sorry for the experience you had with Tactile Medical. /Contents 53 0 R The pump has helped you achieve significant results. /Count 7 (6Kjw_XGz'g &p I wish you success! We rely on the generosity of individuals and sponsors who support our mission and activities. /Resources << 0 T When I first went to physical therapy, she was running through some more common contibuters to swelling. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Biomedical Optics Express. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. I only make 12k per year so its not like I can afford anything. O ce they are used the government wont always them to use them on another. My therapist said they cannot be reused by another. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Except for my wrist, all my measurements showed reduction. 2013; Vol. /ExtGState << /Rect [40.95 36 85.101 45.216] We were asked to improve the ease of donning . Surprisingly, my therapists measurements showed minimal difference with previous measurements. Any circumstance where increased lymphatic or venous return is undesirable 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. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /Type /Page 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. /S /Transparency Michelin Man came to mind as I stretched out on the couch. It takes just 32 minutes per day. Pembrolizumab plus cetuximab in patients with recurrent . You have reached the maximum number of saved studies (100). It delivers a noninvasive therapy that patients can administer themselves at home. << /F 4 endobj >> Positive value shows an increase in swelling. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Its been tough . /MediaBox [0.0 0.0 612.0 792.0] 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. In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. /StructParents 6 Required fields are marked *. I cant explain that but I can visually see a difference. Refer to the Legal Notice for express terms of use. Both Ease of Use/Satisfaction will be assessed by survey. /TT0 69 0 R Material and methods Design and participants Its New, Your email address will not be published. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. >> The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. /C2_0 21 0 R A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Reading or watching TV are the activities Im able to do while Im being treated. JAMA Dermatol. << Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /C2_1 55 0 R Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. So we appealed 3 times. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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. 35 0 R] /Rect [90.257 252.64 421.33 266.44] When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. ? 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. >> 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.