/Filter /FlateDecode Negative value shows a decrease in quality of life/overall health. If Im out late, I use it in the morning and then resume again in the evening. Biomedical Optics Express. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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 cant explain that but I can visually see a difference. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /CropBox [0.0 0.0 612.0 792.0] /CS /DeviceRGB 3 0 obj /CS /DeviceRGB I would suggest you keep contacting Tactile Medical. /TT2 72 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. 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. Out of my sleeve, my 3/4 length sleeves arent as tight. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Tactile Systems Technology, Inc. /MediaBox [0.0 0.0 612.0 792.0] 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 . Positive value shows an increase in Function/Range of Motion. 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. 2015 51 (431-437), 1. Hope it works out. /A << I didnt need a lymphedema physical therapist but too much to explain here. Im only 44 years old , and I have kids that need mom back. /CropBox [0.0 0.0 612.0 792.0] /Subtype /Link /Type /Action (Clinical Trial). >> Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment /TT1 57 0 R stream Actually they dont know much about lymphedema. Developing Lymphedema and not being able to get the help that I neededwas awful. >> PW!\v(jfz:yX 8$W"wqHbxQDL /Subtype /Link The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /TT3 52 0 R Lymphedema The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck 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. Hi Jaime, Im hopeful that your new pump will provide relief. >> The leg garments that I received are for a much taller person. 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. phone: +1 (623) 738-9011 (57) Webstore 3. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /BS << /Font << /Type /Page /C2_0 48 0 R I always start with the one hour full arm and core setting. << >> /URI (http://www.fda.gov/) /CropBox [0 0 612 792] {%AIqEWRA>, Study record managers: refer to the Data Element Definitions if submitting registration or results information. Since using the Flexitouch for almost a year, she had not experienced cellulitis. The lymphedema seen in patients treated for head . My insurance paid for all of it and the Tactile rep will help you get that. /Annots [10 0 R 11 0 R 12 0 R] I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Flexitouch Plus provides flexible program options. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 5. 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. The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. 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. 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 have been having weekly physical therapy to help with lymphedema and range of motion issues. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Do you know of anyone whom would want to buy it? 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! I still need to wear night garments and flat knit garmets and compression bras and self MLD but I feel like a weight has been lifted literally and physically. /Resources << 16 0 obj 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. She explained that compression pumps force air into sleeves with multiple chambers. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 4? HTo0~G6)BjH7u Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. >> /Rotate 0 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 . Yay! They are in contact with patients who could benefit from a pneumatic pump. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. You are benefiting the lymphedema community. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 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. A healthy lymphatic system moves lymph fluid throughout the body. Text, image, video. 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. /Type /Page I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. endobj /C2_1 55 0 R During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. * American Society of Clinical Oncology 1. 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. Sign up today for your free Reader Account. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. I have a uniboot compressions on both of my calves. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). You have reached the maximum number of saved studies (100). I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Toll-free: 1.833.3TACTILE (1.833.382.2845) (6Kjw_XGz'g &p Positive value shows an increase in pain. /Count 7 Can I use the machine on lower limbs with compression garments above? endobj I like to joke, Honey, time for me to put the squeeze on you Phone: 1.612.355.5100 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. 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. >> We were asked to improve the ease of donning . Any circumstance where increased lymphatic or venous return is undesirable 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. 1. When I first went to physical therapy, she was running through some more common contibuters to swelling. /Type /Page >> /Length 470 Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. 5 0 obj G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp >> I have little confidence that the FaceTime call offered will be of much use. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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 The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. /CropBox [0 0 612 792] /Tabs /S >> /ProcSet [/PDF /Text] I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. >> Negative value shows a decrease in swelling. /S /URI Search. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /URI (http://www.fda.gov/) 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 have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 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. endobj Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /Rotate 0 Yes. >> 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. 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. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. He just never could get use to using it and being able to don the garments. When I called my surgeon, he recommended that I not use the FlexiTouch on my chest because the compression can make the tissue expander rupture. I just received it yesterday and Im super hopeful that it will help. /Rect [40.95 36 85.101 45.216] YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! >> Support Care Cancer (2020). /W 0 Reading or watching TV are the activities Im able to do while Im being treated. 9 0 obj The Flexitouch System is not used for nor intended for use to treat cellulitis. /Resources << 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. /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] /XObject << Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Choosing to participate in a study is an important personal decision. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N << 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 Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. The Head & Neck Program is just 32 minutes long. Thanks. 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. Keep sharing your story. Its been tough . 17 0 obj Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. /TT0 23 0 R << If you still have the system, I am interested. I have it in both of my legs mostly in my thighs. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /Type /Group >> September 30, 2021 09:03 ET The pump is awesome works for me iam walking better @ standing the swelling goes away!!! I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). All stars. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. >> endstream 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. Negative value shows a decrease in Function/Range of Motion. 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. So for almost every night for the next seven years I sat down and performed MLD on my left arm. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Words like new kind of pump, different than the old types, favorable studies, and Dr. stream /C2_0 21 0 R If anyone has one, or knows of one, please contact me. Flexitouch . Its brand new, used 1 time. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /Rotate 0 To pump or not to pumpthat is a question that I hear in the lymphedema community. /Type /Page The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. History of the Northwest Lymphedema Center. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /Type /Pages << Michelin Man came to mind as I stretched out on the couch. /Type /Page 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. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually.
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