flexitouch plus head and neck flexitouch plus head and neck

When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. I chatted with a woman from Tacoma and another from Idaho. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /TT2 71 0 R September 30, 2021 09:03 ET Numerous clinical studies show achievement of major clinical benefits and cost savings endobj I didnt need a lymphedema physical therapist but too much to explain here. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 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. >> 2. /Resources << /Group << 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. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp Flexitouch Pd32-u Lymphedema Treatment System Pump. Its amazing how we are communicating so much more through technology because of Covid. History of the Northwest Lymphedema Center. For general information, Learn About Clinical Studies. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. >> Write a review. /CropBox [0 0 612 792] >> Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ Actually they dont know much about lymphedema. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. /Rect [90.257 252.64 421.33 266.44] /Type /Group 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. The Flexitouch System is not used for nor intended for use to treat cellulitis. I dont know if it will make a difference. /Subtype /Link 7 0 obj /Resources << Phone: 1.612.355.5100 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. Support Care Cancer (, 2020). /C2_0 54 0 R Support Care Cancer (2020). 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. Rz:MzI6 6 0 obj Study record managers: refer to the Data Element Definitions if submitting registration or results information. The woman from Idaho said her arm was softer and found the machine easy to use. endobj Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. /BS << I have been having weekly physical therapy to help with lymphedema and range of motion issues. /TT2 58 0 R Last updated March 2021. 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. by Flexitouch. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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 I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. >> Please remove one or more studies before adding more. 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. k /Im0 24 0 R 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 did a baseline measurement of my left arm before treatment and three weeks after using the pump. I used it a few times and Im good now. 1. Top reviews. << I have little confidence that the FaceTime call offered will be of much use. It delivers a noninvasive therapy that patients can administer themselves at home. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /Filter /FlateDecode As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. 12 0 obj The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. 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. >> Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Pembrolizumab plus cetuximab in patients with recurrent . Study record managers: refer to the Data Element Definitions if submitting registration or results information. /C2_1 55 0 R So for almost every night for the next seven years I sat down and performed MLD on my left arm. 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. 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. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. 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. Heart failure (acute pulmonary edema, decompensated acute heart failure) /F 4 Flexitouch . Another set of pads enveloped my left thigh and trunk. 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. /Filter /FlateDecode K-ZB: Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). For more information, https://tactilemedical.com/about-us/. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Resources << & weigh 126 lbs. 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. 8 0 obj Numerous garment and program options to meet each patient's unique treatment needs Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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 Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. /S /URI >> /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) >> The Head & Neck Program is just 32 minutes long. Ive had my Flexitouch for almost five months. >> Support Care Cancer (2020). During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. 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. So we appealed 3 times. Breast cancer and treatment in itself was an awful journey. Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! Hi Deborah, How wonderful you have had such positive success with your pump. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 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. 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. Pain will be assessed using the VAS Pain Scale. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Thanks. /GS0 37 0 R /Resources << Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Surprisingly, my therapists measurements showed minimal difference with previous measurements. phone: +1 (623) 738-9011 (57) Webstore 3. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 11 0 obj {%AIqEWRA>, Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Both Ease of Use/Satisfaction will be assessed by survey. I am looking for a left arm garment for the flexitouch plus. 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. << He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Muluk SC, Hirsch AT, Tafe EC. Its brand new, used 1 time. >> Positive value shows an increase in symptoms/problems. /Type /Page 2. Learn how your comment data is processed. /A << My Experience with the Flexitouch Pneumatic Pump for Lymphedema. /StructParents 2 18 0 obj I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. /MediaBox [0 0 612 792] 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. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. https://doi.org/10.1007/s00520-020-05540-8, 3. Talk with your doctor and family members or friends about deciding to join a study. | Source: Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. Negative value shows a decrease in quality of life/overall health. /TT0 23 0 R I need help but theres a no return policy. Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. Material and methods Design and participants Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. 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. 1. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ HQK0)I46IC">bY3oons} K.4V./`\f0 Fs Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. It was up to me to piece it together. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. If Im out late, I use it in the morning and then resume again in the evening. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. Its something Im passionate about. Its my new normal and Im thankful!! stream Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. /Filter /FlateDecode stream I greatly encourage others to try to obtain one if they are able and if it is a good option for them. 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 bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. endobj They are programed for each individual. This is not anadvertisement for Flexitouch.). The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency /Type /Catalog /S /Transparency /CropBox [0 0 612 792] To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] I didnt make a decision to purchase a pump that day. 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. It has made my life miserable. My interest in pumps suddenly skyrocketed! /TT1 50 0 R 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. x Why Should I Register and Submit Results? Keep sharing your story. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /Length 585 Explain the situation to them. My skin appears more like the skin on my right arm. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /TT3 52 0 R 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. /CropBox [0.0 0.0 612.0 792.0] Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. Its amazing to me how little doctors know about lymphedema. /Type /Group You have reached the maximum number of saved studies (100). Negative value shows a decrease in Function/Range of Motion. Thank you for writing. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. I would be interested to hear how your husbands experience with his new pump. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 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. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. stream 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. 3. D/N500187-000-00 Rev. I have a uniboot compressions on both of my calves. You have reached the maximum number of saved studies (100). Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. 2010; Vol. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Positive value shows an increase in quality of life/overall health. /A << 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. How customer reviews and ratings work See All Buying Options. Last updated March 2021. /Length 680 /TT2 51 0 R /Contents 53 0 R https://doi.org/10.1007/s00520-020-. >> Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Rotate 0 Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. It has become so bad that I can barely walk. /Font << The feeling of devloping a chronic disease after surviving cancer was almost debilitating.