We rely on the generosity of individuals and sponsors who support our mission and activities. /Rect [40.95 36 85.101 45.216] To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. They are in contact with patients who could benefit from a pneumatic pump. PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and You have reached the maximum number of saved studies (100). Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. 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. 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. 2015 51 (431-437), 1. 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. I wish you success! Please cross your fingers for me that this works. >> endobj They use them in the morning, at nightand feel very lucky.. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. endstream What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. /CropBox [0.0 0.0 612.0 792.0] +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. /TT0 69 0 R << /Filter /FlateDecode 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. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /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] /S /Transparency Choosing to participate in a study is an important personal decision. 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. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. So for almost every night for the next seven years I sat down and performed MLD on my left arm. >> /Length 412 /TT2 72 0 R /Type /Pages Last updated March 2021. >> >> Free shipping for many products! 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. /C2_0 21 0 R 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. Tens of thousands of. endobj I would be interested to hear how your husbands experience with his new pump. When she said piano I froze. I had a mastectomy and 9 lymph nodes removed 3 months ago. I have it in both of my legs mostly in my thighs. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use }3eIH]^p~>_ y#h`*#OPQB_lVI"p! >> Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. I have been suffering from lymphedema for the past 2 years. Study record managers: refer to the Data Element Definitions if submitting registration or results information. September 30, 2021 09:03 ET Daily storage of Flextouch system - Lymphedema - Inspire Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /StructParent 1 /BS << >> The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. PW!\v(jfz:yX 8$W"wqHbxQDL Biomedical Optics Express. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. /TT0 49 0 R Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 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. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. 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. Its amazing to me how little doctors know about lymphedema. /Type /Action Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. 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. To pump or not to pumpthat is a question that I hear in the lymphedema community. Tens of thousands of. /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 I cannot find any shoes that fit my feet or any pants that fit comfortably . Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . 7 0 obj Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. The head & neck of non-human animals - /Tabs /S She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Im only 44 years old , and I have kids that need mom back. /Font << When I first went to physical therapy, she was running through some more common contibuters to swelling. 0 T My lymphedema therapist also told me that the pumps werent worth it. 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. I just received the flexitouch plus, but I think the leg garments are too big. /StructParents 6 It delivers a noninvasive therapy that patients can administer themselves at home. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Text, image, video. I decided to purchase one without insurance. /StructParents 0 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch /A << The whole process, though limiting my ambulation, was comfortable and relaxing. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Rz:MzI6 The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. (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. 16 0 obj Lymphedema - Head and Neck Cancer Alliance >> 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. They are programed for each individual. Hope it works out. Minneapolis, MN 55416 USA News Release Details - Tactile Systems Technology, Inc. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. >> /TT0 23 0 R About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Developing Lymphedema and not being able to get the help that I neededwas awful. Hi Karyn, I will post your comment and see if Sarah still has the pump available. %PDF-1.4 Phone: 1.612.355.5100 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Yes. 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. Lymphedema Please remove one or more studies before adding more. /Subtype /Link {%AIqEWRA>, Negative value shows a decrease in symptoms/problems. /TT1 57 0 R 2013; Vol. /Type /Page /Parent 2 0 R HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ >> Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. 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. /Im0 60 0 R >> (6Kjw_XGz'g &p /CS /DeviceRGB /A << The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Search. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. endobj I didnt make a decision to purchase a pump that day. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Type /Group 11 0 obj What really gripes me is that my nurse practitioner wouldnt even consider ordering one. 14(4): p. 198-205. /CropBox [0.0 0.0 612.0 792.0] content.edgar-online.com Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. 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.. /Group << [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. /Annots [39 0 R] Thank you for sharing your husbands success with a pump. Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Michelin Man came to mind as I stretched out on the couch. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. She explained that compression pumps force air into sleeves with multiple chambers. trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. 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 just received it yesterday and Im super hopeful that it will help. Lymphat Res Biol. Minneapolis, MN 55416 USA 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 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. Type of Use (Select one or both, as applicable) lXI . Its New, Your email address will not be published. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Ridner, S.H., Dietrich, M.S., Deng, J. et al. All stars. I have one new for sale. I only make 12k per year so its not like I can afford anything. 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. Yes, taking care of ones body requires several interventions. So we appealed 3 times. I cant explain that but I can visually see a difference. Dr. Shelia Ridner Dr. Barbara Murphy 2. stream I know many others can as well. /Length 680 /Resources << The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource Write a review. /S /URI << 4 0 obj /Type /Group Then I got my flexitouch and my life changed. >> /TT0 69 0 R 2016;14(4):198205. /Length 498 Tactile Medical Announces Enrollment of First Patient in 2. My go to place when I need calming. Just wondering if you have any ideas of whom to contact on such a thing. /Parent 2 0 R Oral Oncology. Ive heard from many people that they saw good results with their pump. 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. /Rect [90.257 252.64 421.33 266.44] >> 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. >> Choosing to participate in a study is an important personal decision. x Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. /Font << << /Resources << stream He just never could get use to using it and being able to don the garments. /TT2 74 0 R I can relate all too well to what you have been through. 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. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. 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. The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. endobj 15 0 obj /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. For general information, Learn About Clinical Studies. 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. >> Talk with your doctor and family members or friends about deciding to join a study. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. 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. /F 4 The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Positive value shows an increase in pain. Positive value shows an increase in swelling. Actually they dont know much about lymphedema. << 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. /Contents 73 0 R I was told purchased high priced left garments which I dont think I needed. 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 Plus system has been clinically proven to stimulate the lymphatic system. endstream /MediaBox [0.0 0.0 612.0 792.0] Support Care Cancer (2020). /StructParents 0 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. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. >> /StructParents 7 HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Buying a reconditioned machine saved me some money. Learn how your comment data is processed. << Why Should I Register and Submit Results? Since using the Flexitouch for almost a year, she had not experienced cellulitis. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. >> I?m 5? I chatted with a woman from Tacoma and another from Idaho. D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, 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/. Medical Device Innovation | Nottingham Spirk Design Collaborative 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. It takes just 32 minutes per day. /Contents 75 0 R In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Tactile Systems debuts Flexitouch head and neck lymphedema treatment >> I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. /Length 470 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. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /CropBox [0.0 0.0 612.0 792.0] Phone: 1.612.355.5100 1. /Parent 2 0 R . I have a uniboot compressions on both of my calves. Minneapolis, MN 55416 USA My Experience with the Flexitouch Pneumatic Pump for Lymphedema Explain the situation to them. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Most significantly was the reduction in my forearm. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. /Type /Page The Head & Neck Program is just 32 minutes long. /ProcSet [/PDF /Text] Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Lymphat Res Biol. 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. I always start with the one hour full arm and core setting. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. /Filter /FlateDecode Listing a study does not mean it has been evaluated by the U.S. Federal Government. /CS /DeviceRGB Subject Quality of Life will be assessed using EORTC C30 questionnaire. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Clinical Trial on Head and Neck Cancer: Flexitouch Plus system Study record managers: refer to the Data Element Definitions if submitting registration or results information. 3701 Wayzata Blvd, Suite 300 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). Negative value shows a decrease in pain. The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. It delivers a noninvasive therapy that patients can administer themselves at home. endobj 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. Toll-free: 1.833.3TACTILE (1.833.382.2845) 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.
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