flexitouch plus head and neck

Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. endobj I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. /C2_0 54 0 R bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. A healthy lymphatic system moves lymph fluid throughout the body. The whole process, though limiting my ambulation, was comfortable and relaxing. /CropBox [0 0 612 792] /TT1 70 0 R >> 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. /Group << My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Last updated March 2021. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Any circumstance where increased lymphatic or venous return is undesirable NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. >> /TT2 58 0 R 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. Deng J, et al. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. Pembrolizumab plus cetuximab in patients with recurrent . >> This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Chronic Wounds 1(1): 114125. 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 Since using the Flexitouch for almost a year, she had not experienced cellulitis. /MediaBox [0.0 0.0 612.0 792.0] Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /CropBox [0 0 612 792] /CS /DeviceRGB Study record managers: refer to the Data Element Definitions if submitting registration or results information. /Length 585 (6Kjw_XGz'g &p (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. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N The head & neck of non-human animals - | Cambridge SMART Vocabulary >> ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. >> << Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. PW!\v(jfz:yX 8$W"wqHbxQDL Required fields are marked *. My skin appears more like the skin on my right arm. Positive value shows an increase in swelling. 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. endobj /Annots [39 0 R] It was a blow to the life I had that I once had. >> The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. You have reached the maximum number of saved studies (100). Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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.. /Filter /FlateDecode A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. 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. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 1. 12 0 obj /Filter /FlateDecode Subject overall health and quality of life in the past week-EORTC C30. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. endstream 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. They will reach out to Flexitouch in the process of creating a segment for the news. 1. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /S /URI I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /S /Transparency 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. Muluk SC, Hirsch AT, Tafe EC. Words like new kind of pump, different than the old types, favorable studies, and Dr. /Parent 2 0 R /Tabs /S It has made my life miserable. /Rect [40.95 36 85.101 45.216] /W 0 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. 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. /CropBox [0.0 0.0 612.0 792.0] 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. 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. EJVES. Tens of thousands of. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /TT3 52 0 R endobj Text, image, video. You have reached the maximum number of saved studies (100). Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. /CropBox [0.0 0.0 612.0 792.0] 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. /C2_0 21 0 R /Version /1.4 /TT3 59 0 R 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! Numerous clinical studies show achievement of major clinical benefits and cost savings 35 0 R] 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday, 3701 Wayzata Blvd, Suite 300 /MediaBox [0.0 0.0 612.0 792.0] << The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). /C2_0 38 0 R Support Care Cancer (2020). /TT0 69 0 R The lymphedema seen in patients treated for head . 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. /Length 450 /F 4 The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. /Rotate 0 Upper set (head and neck). Its amazing to me how little doctors know about lymphedema. stream I use it every evening. /StructParents 6 endobj endobj 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.. Hi Wandalynn . /F 4 /TT0 56 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. /Rotate 0 /Pages 2 0 R >> I am looking for a left arm garment for the flexitouch plus. /ProcSet [/PDF /Text] I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 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 pump is called the Flexitouch System by Tactile Medical. 17 0 obj /Type /Group An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Talk with your doctor and family members or friends about deciding to join a study. I wish you success! 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. I would suggest you keep contacting Tactile Medical. 14(4): p. 198-205. /Filter /FlateDecode So for almost every night for the next seven years I sat down and performed MLD on my left arm. /Type /Pages Hopefully it will give me a better quality of life because I dont know what else to do at this point. I chatted with a woman from Tacoma and another from Idaho. If Im out late, I use it in the morning and then resume again in the evening. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). I dont know if it will make a difference. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Lymphat Res Biol, 2016. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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. I just finished 6 weeks of radiation. >> Buying a reconditioned machine saved me some money. I was told purchased high priced left garments which I dont think I needed. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 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. Flexitouch . Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. 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. /Font << The woman from Idaho said her arm was softer and found the machine easy to use. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. 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. Sign up today for your free Reader Account. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Please remove one or more studies before adding more. Adams, KE, Rasmussen JC, Darne C, et al. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. /Resources << /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 | Source: Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. 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. I have a uniboot compressions on both of my calves. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Negative value shows a decrease in pain. endobj Pain will be assessed using the VAS Pain Scale. 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. /Length 680 As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. /Contents 75 0 R The Flexitouch 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 . 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. Positive value shows an increase in quality of life/overall health. 2013; Vol. 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. 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. 7nwJ@6]?t~.} Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. endobj The content is not intended to substitute manufacturer instructions. endobj It takes just 32 minutes per day. 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. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. K-ZB: The warranty was the same as a new machine. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 Choosing to participate in a study is an important personal decision. /S /Transparency /Resources << I dont like that I have to do it but it has changed my legs back to normal. The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! Michelin Man came to mind as I stretched out on the couch. They are programed for each individual. . Hi Kristie, Thank you for sharing your story. It takes just 32 minutes per day. Support Care Cancer (2020). Learn More Take the steps now to help your head and neck cancer survivors. >> 2008-2023 HMP Global, Inc. All rights reserved. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? It delivers a noninvasive therapy that patients can administer themselves at home. The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. 3 0 obj Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Font << endobj 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. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Support Care Cancer (2020). 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/. /StructParents 7 << The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. 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) >> Lymphat Res Biol. 4. /ProcSet [/PDF /Text] 4? 2015 51 (431-437), 1. Im sorry for the experience you had with Tactile Medical. Has anyone else had any experience with this? 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. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Many head and neck cancer survivors are faced with an additional challenge: lymphedema. My therapist said they cannot be reused by another. /W 0 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. Lymphat Res Biol. Keep in touch! 2 0 obj Yes, taking care of ones body requires several interventions. Flexitouch Pd32-u Lymphedema Treatment System Pump. /TT2 71 0 R So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. 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. /MediaBox [0 0 612 792] Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. Negative value shows a decrease in swelling. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. /Length 412 Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. 1 0 obj The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Faced with negative publicity, they often end up making things right. Type of Use (Select one or both, as applicable) lXI . 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. /Length 498 Tactile Systems Technology, Inc. >> 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. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /MediaBox [0.0 0.0 612.0 792.0] HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /TT0 69 0 R << I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. . Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Its my new normal and Im thankful!! /MediaBox [0 0 612 792] Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. Thank you for writing. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Both Ease of Use/Satisfaction will be assessed by survey. UGH! Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional 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 ] /StructParent 1 endstream << endobj Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. endobj 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. /Tabs /S We rely on the generosity of individuals and sponsors who support our mission and activities. It has become so bad that I can barely walk. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /Annots [10 0 R 11 0 R 12 0 R] 18 0 obj See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Biomedical Optics Express. Another set of pads enveloped my left thigh and trunk. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Hi Kathi, The FaceTime call might work! stream I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. << 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. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Its brand new, used 1 time.

flexitouch plus head and neck 2023