To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts 2013; Vol. Thank you for sharing and being an advocate for lymphedema! /BS << /StructParents 0 endstream I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. 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. 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. << 6 0 obj HTo0~G6)BjH7u Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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! Minneapolis, MN 55416 USA Its amazing to me how little doctors know about lymphedema. /Resources << 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. Lymphedema - Head and Neck Cancer Alliance Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /StructParents 0 Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Im a pianist and its become my safe place. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. endobj 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/. /Version /1.4 /Type /Pages Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. What is encouraging is that you have had success with managing your lymphedema! Advanced Techniques in Canine and Feline Neurosurgery 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. It delivers a noninvasive therapy that patients can administer themselves at home. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp >> Michelin Man came to mind as I stretched out on the couch. where is the compassion for ill people that NEED certain healthcare to get better? << In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. %PDF-1.4 /Type /Page YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! I greatly encourage others to try to obtain one if they are able and if it is a good option for them. 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. endobj /Type /Action The lymphedema seen in patients treated for head . No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /Resources << >> Flexitouch Pd32-u Lymphedema Treatment System Pump stream /ProcSet [/PDF /Text /ImageC] /Font << /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] HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. >> Percent change is calculated by the difference between scores averaged at 6 months versus baseline. It seems a lot of pumps are preprogrammed for the individual. 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). Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. 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 wonder if pumps can be reprogrammed. << Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /C2_0 54 0 R Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. You are benefiting the lymphedema community. Positive value shows an decrease in quality of life. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. It takes just 32 minutes per day. 11 0 obj ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN H]O0+=) ES See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 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. >> 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. /W 0 It delivers a noninvasive therapy that patients can administer themselves at home. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /Filter /FlateDecode Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. endstream Please cross your fingers for me that this works. /Parent 2 0 R I did a baseline measurement of my left arm before treatment and three weeks after using the pump. https://doi.org/10.1007/s00520-020-. * American Society of Clinical Oncology 1. >> 18 0 obj endobj /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 You have reached the maximum number of saved studies (100). In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. 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 pump has helped you achieve significant results. /Parent 2 0 R /Subtype /Link >> Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) >> The leg garments that I received are for a much taller person. 4. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. The woman from Idaho said her arm was softer and found the machine easy to use. We were asked to improve the ease of donning . 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 0 612 792] Phone: 1.612.355.5100 Tens of thousands of. I have it in both of my legs mostly in my thighs. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. << /Type /Page The warranty was the same as a new machine. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /Type /Group 14(4): p. 198-205, 2. PDF Lauren Barnes - Food and Drug Administration Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Type of Use (Select one or both, as applicable) lXI . Positive value shows an increase in quality of life/overall health. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. /ProcSet [/PDF /Text] /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 contact information provided by the sponsor. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Advanced pneumatic compression for treatment of lymphedema of the head 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. My best to you. Head and Neck Cancer Lymphedema - Tactile Medical Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 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. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Pain will be assessed using the VAS Pain Scale. 1. /TT0 69 0 R /Count 7 /CropBox [0 0 612 792] 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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /MediaBox [0.0 0.0 612.0 792.0] He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. https://doi.org/10.1007/s00520-020-05540-8, 3. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Length 680 Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. 15 0 obj 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. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. My lymphedema therapist also told me that the pumps werent worth it. Swelling will be assessed using the ALOHA measurement protocol. Most significantly was the reduction in my forearm. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Lymphat Res Biol. Keep sharing your story. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. Actually they dont know much about lymphedema. 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. 7nwJ@6]?t~.} Muluk SC, Hirsch AT, Tafe EC. It was up to me to piece it together. >> Flexitouch Plus - Treat Head & Neck Swelling At Home with This 35 0 R] by Flexitouch. ? >> The pump is called the Flexitouch System by Tactile Medical. /Group << 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. << Daily storage of Flextouch system - Lymphedema - Inspire Flexitouch System | Dynamic Compression | Home Therapy - WoundSource /C2_0 21 0 R 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. 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. >> 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. >> /Filter /FlateDecode 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. Overview Product Features Details Benefits Dr. Shelia Ridner Dr. Barbara Murphy It delivers a noninvasive therapy that patients can administer themselves at home. 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. Its also a relief not to manually MLD my arm every night. Thank you for sharing your husbands success with a pump. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. If Im out late, I use it in the morning and then resume again in the evening. He just never could get use to using it and being able to don the garments. 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. /ExtGState << The feeling of devloping a chronic disease after surviving cancer was almost debilitating. Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. 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.. /CS /DeviceRGB I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. (Note: There are other well regarded pumps on the market. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 17 0 obj /TT1 70 0 R One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Do you know of anyone whom would want to buy it? Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) I chatted with a woman from Tacoma and another from Idaho. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I cant explain that but I can visually see a difference. >> How customer reviews and ratings work See All Buying Options. All subjects will receive a single intervention. /F 4 << Subject overall health and quality of life in the past week-EORTC C30. /Type /Action 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. Your email address will not be published. Text, image, video. S 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 /Contents 75 0 R << << {%AIqEWRA>, The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. It has become so bad that I can barely walk.