flexitouch plus head and neck

Percent change is calculated by the difference between scores averaged at 6 months versus baseline. You are benefiting the lymphedema community. /Tabs /S I used it a few times and Im good now. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. 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. Negative value shows a decrease in swelling. << Numerous clinical studies show achievement of major clinical benefits and cost savings Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 5 0 obj Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] Hope it works out. >> Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. 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/. 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. /Type /Page Negative value shows a increase in quality of life. When I first went to physical therapy, she was running through some more common contibuters to swelling. UGH! The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /Im0 24 0 R My skin appears more like the skin on my right arm. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . 7nwJ@6]?t~.} Keep in touch! Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. 2. >> /StructParents 0 I was rather startled at how wrapped up I was. I wonder if pumps can be reprogrammed. Thanks. /Version /1.4 https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. << 5. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Font << Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 3 0 obj 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. 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. 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 Thank you for sharing and being an advocate for lymphedema! Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Text, image, video. << x 14 0 obj /MediaBox [0 0 612 792] Biomedical Optics Express. 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. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 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) 17 0 obj 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. endobj The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. /BS << Everything in my life that I do and love and I am passionate about invloves using my hands and arms. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Looking at his ankles there IS no swelling now. Buying a reconditioned machine saved me some money. /Rotate 0 >> Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. >> If you still have the system, I am interested. Tactile Systems Technology, Inc. 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. 35 0 R] What really gripes me is that my nurse practitioner wouldnt even consider ordering one. It takes just 32 minutes per day. 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. Upper set (head and neck). H]O0+=) ES /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. * American Society of Clinical Oncology 1. /BS << 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. Out of my sleeve, my 3/4 length sleeves arent as tight. /Tabs /S 14(4): p. 198-205. The Flexitouch System is not used for nor intended for use to treat cellulitis. September 30, 2021 09:03 ET I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 1. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /Resources << Its also a relief not to manually MLD my arm every night. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. /CS /DeviceRGB by Flexitouch. /Resources << /ProcSet [/PDF /Text /ImageC] Yes, taking care of ones body requires several interventions. /CS /DeviceRGB 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. >> I have a pump system left and right leg also stomach wraps. Faced with negative publicity, they often end up making things right. /Type /Group Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. 16 0 obj 12 0 obj Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. S /Rotate 0 /Resources << >> 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. 18 0 obj >> Phone: 1.612.355.5100 What is encouraging is that you have had success with managing your lymphedema! Hi Kristie, Thank you for sharing your story. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. Minneapolis, MN 55416 USA I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. I would be interested to hear how your husbands experience with his new pump. >> 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. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! Just wondering if you have any ideas of whom to contact on such a thing. /StructParents 0 I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. Positive value shows an increase in pain. >> /W 0 Thumbs up for Flexi-Touch!! 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. Phone: 1.612.355.5100 stream endstream 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. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. /Type /Page Dr. Shelia Ridner Dr. Barbara Murphy Last updated March 2021. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /TT2 74 0 R I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. I decided to purchase one without insurance. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. stream The pump is called the Flexitouch System by Tactile Medical. But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. << I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /Font << The pump has helped you achieve significant results. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /Resources << 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. >> 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 >> https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Flexitouch . << >> I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. They are usually called something like 7 on your side or Channel 3 helps you. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Support Care Cancer (2020). /Rect [40.95 36 85.101 45.216] 2015 51 (431-437), 1. /Length 412 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 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. >> Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. [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 just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. I only make 12k per year so its not like I can afford anything. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. (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. Words like new kind of pump, different than the old types, favorable studies, and Dr. /Filter /FlateDecode Talk with your doctor and family members or friends about deciding to join a study. /F 4 Most significantly was the reduction in my forearm. /Annots [39 0 R] The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. I cannot find any shoes that fit my feet or any pants that fit comfortably . I need help but theres a no return policy. /MediaBox [0.0 0.0 612.0 792.0] >> I have lymphedema near globally at this point and am trying to obtain coverage via insurance. << For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. 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.. 14(4): p. 198-205, 2. << 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. >> << Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? /TT0 22 0 R Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. endobj 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. /ExtGState << 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. /StructParents 6 /Type /Catalog A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. My husband?s pump system arrived yesterday. You have reached the maximum number of saved studies (100). As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. 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. 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.. /S /URI /CropBox [0.0 0.0 612.0 792.0] 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. /C2_0 38 0 R Karaca-Mandic P, Hirsch AT, Rockson SG, et al. /Parent 2 0 R /Font << Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. Learn how your comment data is processed. /Type /Page 2 0 obj /Rotate 0 First of all I cant drive, and second I have to pay a $60 copay every time I go. Tens of thousands of. Please cross your fingers for me that this works. >> Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. Talk with your doctor and family members or friends about deciding to join a study. You have reached the maximum number of saved studies (100). doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. Learn More Take the steps now to help your head and neck cancer survivors. 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. My go to place when I need calming. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. 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. 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. Do you know of anyone whom would want to buy it? >> 2. I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. I didnt need a lymphedema physical therapist but too much to explain here. >> {%AIqEWRA>, /Type /Page I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] It delivers a noninvasive therapy that patients can administer themselves at home. HTo0~G6)BjH7u /Type /Page This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. All subjects will receive a single intervention. Numerous garment and program options to meet each patient's unique treatment needs I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. Surprisingly, my therapists measurements showed minimal difference with previous measurements. All stars. /StructParent 1 1. /CropBox [0 0 612 792] /S /Transparency % I use it everyday for an hour. 4? I just received the flexitouch plus, but I think the leg garments are too big. 0 T Positive value shows an increase in quality of life/overall health. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. PW!\v(jfz:yX 8$W"wqHbxQDL /W 0 /StructParents 0 My best to you. Pain will be assessed using the VAS Pain Scale. /TT2 71 0 R Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. 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. I have a uniboot compressions on both of my calves. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Another set of pads enveloped my left thigh and trunk. /TT0 23 0 R Muluk SC, Hirsch AT, Tafe EC. During pregnancy (applies only to the Flexitouch Plus trunk accessory). endobj For more information, https://tactilemedical.com/about-us/. 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.

flexitouch plus head and neck 2023