3701 Wayzata Blvd, Suite 300 /Count 7 Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. >> Study record managers: refer to the Data Element Definitions if submitting registration or results information. >> 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. /TT3 52 0 R /Pages 2 0 R >> The warranty was the same as a new machine. 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 ] 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. << Can I use the machine on lower limbs with compression garments above? One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. My husband has a brand new system that Im trying to sell. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Developing Lymphedema and not being able to get the help that I neededwas awful. /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] 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. /Font << Hi Jaime, Im hopeful that your new pump will provide relief. I decided to purchase one without insurance. << 18 0 obj /TT1 70 0 R /Type /Page 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. 2. Thumbs up for Flexi-Touch!! I have lymphedema in my right arm, breast and axilla. << This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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. I have a uniboot compressions on both of my calves. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Its New, Your email address will not be published. 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/. /MediaBox [0.0 0.0 612.0 792.0] /Length 470 /Im0 60 0 R The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Venous Ulcers. 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. >> How customer reviews and ratings work See All Buying Options. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Heart failure (acute pulmonary edema, decompensated acute heart failure) Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. The Head & Neck Program is just 32 minutes long. 13 0 obj /StructParents 0 To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /S /Transparency Flexitouch Pd32-u Lymphedema Treatment System Pump. 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 system has been clinically proven to stimulate the lymphatic system. % endstream /StructParents 0 All reviewers. I didnt need a lymphedema physical therapist but too much to explain here. /S /Transparency /Filter /FlateDecode I?m 5? Toll-free: 1.833.3TACTILE (1.833.382.2845) 2 0 obj 5 0 obj https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Tabs /S The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /ProcSet [/PDF /Text] The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. I wanted to talk to some people who had actually used the pump. My interest in pumps suddenly skyrocketed! I just received the flexitouch plus, but I think the leg garments are too big. Support Care Cancer (2020). /GS0 37 0 R 2010; Vol. 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. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! If Im out late, I use it in the morning and then resume again in the evening. /MediaBox [0 0 612 792] 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! Percent change is calculated by the difference between scores averaged at 6 months versus baseline. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. /URI (http://www.fda.gov/) It takes just 32 minutes per day. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Font << Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /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] See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use phone: +1 (623) 738-9011 (57) Webstore 3. /MediaBox [0.0 0.0 612.0 792.0] Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 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. k The pump is called the Flexitouch System by Tactile Medical. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /CS /DeviceRGB For general information, Learn About Clinical Studies. /URI (http://www.fda.gov/) /Rect [90.257 252.64 421.33 266.44] Flexitouch Plus provides flexible program options. Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. 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. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Another set of pads enveloped my left thigh and trunk. Last updated March 2021. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) /C2_0 38 0 R Hi Wally, Hope someone is able to meet your request. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. Talk with your doctor and family members or friends about deciding to join a study. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. I used it a few times and Im good now. 2013; Vol. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 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. Im only 44 years old , and I have kids that need mom back. Top reviews. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Swelling will be assessed using the ALOHA measurement protocol. Breast cancer and treatment in itself was an awful journey. 2016;14(4):198205. Thanks. 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. Faced with negative publicity, they often end up making things right. /S /Transparency /Rect [40.95 36 85.101 45.216] Please cross your fingers for me that this works. /Annots [10 0 R 11 0 R 12 0 R] Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. I have one new for sale. /CropBox [0.0 0.0 612.0 792.0] 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. I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . /Rotate 0 endobj /XObject << << /StructParents 8 Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. 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. 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 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. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. We were asked to improve the ease of donning . 1. Pembrolizumab plus cetuximab in patients with recurrent . In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. 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. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. They are in contact with patients who could benefit from a pneumatic pump. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. /Tabs /S 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. /Tabs /S Sort by. /Contents 53 0 R << Thanks. Minneapolis, MN 55416 USA Support Care Cancer (2020). Negative value shows a decrease in Function/Range of Motion. 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. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) Thank you for sharing and being an advocate for lymphedema! XJ /S /URI Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endobj Text, image, video. << Rockson floated to my ears. 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^ I use it everyday for an hour. >> /Type /Pages 46(4): 480487. /Group << /Type /Action /CropBox [0 0 612 792] Many, many of my patients love their pump. 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. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Toll-free: 1.833.3TACTILE (1.833.382.2845) Percent change is calculated by the difference between scores averaged at 6 months versus baseline. (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. Please write back in a month or so and let us know your progress. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. endobj So for almost every night for the next seven years I sat down and performed MLD on my left arm. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? HTo0~G6)BjH7u The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. I did send them an email and asked them to look at your case again. /S /URI Type of Use (Select one or both, as applicable) lXI . My therapist said they cannot be reused by another. stream !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. /TT3 74 0 R To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Learn how your comment data is processed. My husband?s pump system arrived yesterday. 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. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. (6Kjw_XGz'g &p /F 4 . It has become so bad that I can barely walk.

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