flexitouch plus head and neck flexitouch plus head and neck

Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /XObject << >> >> To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /S /Transparency In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Rect [90.257 252.64 421.33 266.44] >> Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional I wish you success! /BS << /TT2 58 0 R Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ >> The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. You have reached the maximum number of saved studies (100). /Version /1.4 Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 7 0 obj The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. . /Resources << Im only 44 years old , and I have kids that need mom back. During pregnancy (applies only to the Flexitouch Plus trunk accessory). I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 2. /A << >> 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 study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. 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. 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. Its amazing how we are communicating so much more through technology because of Covid. 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. >> The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. /TT1 57 0 R Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! endstream An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 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. eIb? Lymphat Res Biol. 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 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. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. 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 will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. >> Muluk SC, Hirsch AT, Tafe EC. /CropBox [0.0 0.0 612.0 792.0] Lymphedema I was rather startled at how wrapped up I was. /StructParents 0 endobj Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. 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. Talk with your doctor and family members or friends about deciding to join a study. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Dr. Shelia Ridner Dr. Barbara Murphy >> 6 0 obj 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 /TT0 69 0 R JAMA Dermatol. /Tabs /S Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I cant explain that but I can visually see a difference. We were asked to improve the ease of donning . I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Can I use the machine on lower limbs with compression garments above? Venous Ulcers. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Pain will be assessed using the VAS Pain Scale. 1 0 obj I have lymphedema near globally at this point and am trying to obtain coverage via insurance. << endobj And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Positive value shows an increase in pain. << You are benefiting the lymphedema community. Words like new kind of pump, different than the old types, favorable studies, and Dr. 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. 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 ] 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. 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! Material and methods Design and participants 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. /ProcSet [/PDF /Text /ImageC] 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. According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. Support Care Cancer (2020). Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). I would contact your local news station that has a consumer investigation/help line. September 30, 2021 09:03 ET The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. 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. Text, image, video. S 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. endstream UGH! /Type /Page 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 /Resources << /TT0 22 0 R endstream It delivers a noninvasive therapy that patients can administer themselves at home. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. I dont like that I have to do it but it has changed my legs back to normal. 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. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. I really need this system and had such desperate hope. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 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. Two years on pump controller and garments. Hi Kathi, The FaceTime call might work! 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. /Type /Catalog For general information, Learn About Clinical Studies. >> They will reach out to Flexitouch in the process of creating a segment for the news. 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. /Rotate 0 >> Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /A << /Parent 2 0 R 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 . In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. 0 T /Length 680 Support Care Cancer (, 2020). endobj 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. >> & weigh 126 lbs. Any circumstance where increased lymphatic or venous return is undesirable Developing Lymphedema and not being able to get the help that I neededwas awful. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Group << Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /Parent 2 0 R /CropBox [0 0 612 792] Yay! I wanted to talk to some people who had actually used the pump. Hi Karyn, I will post your comment and see if Sarah still has the pump available. /Resources << H]O0+=) ES /Filter /FlateDecode In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. We rely on the generosity of individuals and sponsors who support our mission and activities. Please cross your fingers for me that this works. So we appealed 3 times. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). Oral Oncology. % I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. 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.. Many, many of my patients love their pump. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that.