flexitouch plus head and neck

Hi Deborah, How wonderful you have had such positive success with your pump. /Length 470 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. Positive value shows an increase in Function/Range of Motion. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ >> document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Rotate 0 10 0 obj Pembrolizumab plus cetuximab in patients with recurrent . 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. /Pages 2 0 R https://doi.org/10.1007/s00520-020-05540-8, 3. To pump or not to pumpthat is a question that I hear in the lymphedema community. 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. Search. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Numerous clinical studies show achievement of major clinical benefits and cost savings 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. I just finished 6 weeks of radiation. I need help but theres a no return policy. Talk with your doctor and family members or friends about deciding to join a study. 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. eIb? It takes just 32 minutes per day. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? 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. /A << k /TT0 56 0 R 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. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Minneapolis, MN 55416 USA << /Resources << Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment /A << I have one new for sale. /Type /Action Flexitouch . 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I wonder if pumps can be reprogrammed. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /Rect [40.95 36 85.101 45.216] 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^ 2016;14(4):198205. Keep in touch! The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. Lymphat Res Biol, 2016. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 2015;151(11):11871193. For general information, Learn About Clinical Studies. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. << They are usually called something like 7 on your side or Channel 3 helps you. Write a review. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts 16 0 obj /StructParents 0 2 0 obj /Im0 60 0 R Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I like to joke, Honey, time for me to put the squeeze on you Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Positive value shows an decrease in quality of life. >> This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. >> /CropBox [0 0 612 792] Buying a reconditioned machine saved me some money. 18 0 obj Lymphedema Treatment in Head and Neck Cancer Patients /ProcSet [/PDF /Text /ImageC] PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /StructParent 1 Negative value shows a decrease in quality of life/overall health. D/N500187-000-00 Rev. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Lymphat Res Biol. They are in contact with patients who could benefit from a pneumatic pump. >> The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Thank you for writing. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. endobj My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Tens of thousands of. My skin appears more like the skin on my right arm. Managing my lymphedema requires attention and an assortment of tools. 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. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Actually they dont know much about lymphedema. 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. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /Tabs /S /Length 412 Daily storage of Flextouch system - Lymphedema - Inspire << 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 dont like that I have to do it but it has changed my legs back to normal. I only make 12k per year so its not like I can afford anything. My lymphedema therapist also told me that the pumps werent worth it. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. 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. 14 0 obj /Length 498 << Ive had my Flexitouch for almost five months. History of the Northwest Lymphedema Center. /Count 7 endobj See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Percent change is calculated by the difference between scores averaged at 6 months versus baseline. endobj One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. Subject Quality of Life will be assessed using EORTC C30 questionnaire. 8 0 obj Support Care Cancer (2020). 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. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. /F 4 /MediaBox [0.0 0.0 612.0 792.0] When I first went to physical therapy, she was running through some more common contibuters to swelling. endobj Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] I have it in both of my legs mostly in my thighs. /Rect [40.95 36 85.101 45.216] Positive value shows an increase in quality of life/overall health. << All stars. Its amazing how we are communicating so much more through technology because of Covid. 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. The Head & Neck Program is just 32 minutes long. My interest in pumps suddenly skyrocketed! /C2_0 21 0 R >> Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. The lymphedema seen in patients treated for head . /Type /Page >> /Contents 75 0 R /Rotate 0 Breast cancer and treatment in itself was an awful journey. Material and methods Design and participants So we appealed 3 times. A healthy lymphatic system moves lymph fluid throughout the body. /MediaBox [0.0 0.0 612.0 792.0] I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. Please cross your fingers for me that this works. 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 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! Negative value shows a decrease in swelling. /Subtype /Link You have reached the maximum number of saved studies (100). 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 takes just 32 minutes per day. Minneapolis, MN 55416 USA A Pilot Study to Evaluate the Feasibility and Potential Effectiveness /CropBox [0.0 0.0 612.0 792.0] Minneapolis, MN 55416 USA /Type /Group /TT2 51 0 R >> Im only 44 years old , and I have kids that need mom back. Its New, Your email address will not be published. (6Kjw_XGz'g &p Oral Oncology. /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] >> PDF Lauren Barnes - Food and Drug Administration Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Except for my wrist, all my measurements showed reduction. >> /W 0 The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Positive value shows an increase in symptoms/problems. 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 /Filter /FlateDecode >> It was up to me to piece it together. 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 >> Flexitouch Pd32-u Lymphedema Treatment System Pump. I have a pump system left and right leg also stomach wraps. 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. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /F 4 Lymphat Res Biol. I use it every evening. endobj O ce they are used the government wont always them to use them on another. I chatted with a woman from Tacoma and another from Idaho. Phone: 1.612.355.5100 /Type /Page /TT1 23 0 R /S /URI She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. /Type /Group Reading or watching TV are the activities Im able to do while Im being treated. /TT0 23 0 R I?m 5? /W 0 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. endobj >> Medical Device Innovation | Nottingham Spirk Design Collaborative I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. K-ZB: All subjects will receive a single intervention. << Ml6(|a\!A.;Q#[. 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. Numerous garment and program options to meet each patient's unique treatment needs /GS0 37 0 R >> 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.. I greatly encourage others to try to obtain one if they are able and if it is a good option for them. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 7nwJ@6]?t~.} Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Both Ease of Use/Satisfaction will be assessed by survey. 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. We rely on the generosity of individuals and sponsors who support our mission and activities. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /MediaBox [0 0 612 792] Tactile Medical Announces Enrollment of First Patient in 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. 46(4): 480487. /MediaBox [0 0 612 792] >> /BS << 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.. >> To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Hi Wandalynn . Then I got my flexitouch and my life changed. where is the compassion for ill people that NEED certain healthcare to get better? 35 0 R] Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /CropBox [0.0 0.0 612.0 792.0] The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. I would suggest you keep contacting Tactile Medical. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 2015 51 (431-437), 1. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. << Upper set (head and neck). You have reached the maximum number of saved studies (100). Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. /Annots [10 0 R 11 0 R 12 0 R] << /Font << The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv /CS /DeviceRGB /C2_0 54 0 R For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? >> 3701 Wayzata Blvd, Suite 300 I wish you success! /TT0 22 0 R 7 0 obj 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). https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. /TT1 70 0 R /TT0 49 0 R between head and neck cancer and lymphedema. Support Care Cancer (2020). 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. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N I would contact your local news station that has a consumer investigation/help line. Last updated March 2021. HTo0~G6)BjH7u 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. [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. /Type /Action One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. ? endobj Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. /Type /Pages Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 2013; Vol. 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) . 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.