GI Dynamics Announces Lead Clinical Study Site for US Pivotal Trial of EndoBarrier
July 11, 2019 at 03:54 am IST
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GI Dynamics® Inc. announced the execution of its contract with Brigham and Women's Hospital in Boston, Massachusetts as the lead clinical site of the U.S. pivotal trial of EndoBarrier. The U.S. pivotal trial of EndoBarrier, STEP-1 (Single Therapy Euglycemic Procedure), formally known as GID 18-1, will begin enrolling patients with type 2 diabetes and obesity during the second half of 2019. The primary endpoint of STEP-1 is reduction in average blood sugar levels (HbA1c) at 12-months of treatment. The pivotal trial will consist of randomized EndoBarrier implant and control arms; both arms will receive identical lifestyle therapy that complies with the most current American Diabetes Association guidelines. Brigham and Women's Hospital (Brigham and Women's) is noted for the quality of its health care professionals who dedicate themselves to patient care while pursuing clinical research and enacting innovation. The hospital is ranked among the nation's 20 Best Hospitals according to the U.S. News & World Report in 2018 and 2019; the hospital is listed among Becker Healthcare's 2019 150 Top Places to Work in Healthcare. Brigham and Women's principal investigator (PI), Christopher C. Thompson M.D., M.H.E.S., is an associate professor at Harvard Medical School who specializes in gastroenterology, hepatology and endoscopy. He is a board-certified doctor of internal medicine and gastroenterology, who is both the director of endoscopy and director of the bariatric endoscopy fellowship program at Brigham and Women's. Dr. Thompson is the author or co-author of more than 200 publications and has participated in or le numerous clinical trials.
GI Dynamics, Inc. is a medical device company. The Company designs and applies device and disease management solutions for the treatment of metabolic disease. The Company designs, develops, manufactures and markets medical devices for non-surgical approaches to treat type II diabetes and obesity. The Company's product, EndoBarrier, is an endoscopically-delivered device therapy, which is approved for the treatment of obese type II diabetes with body mass index (BMI) greater than or equal to 30 kilogram/square meter (kg/m2), or obese patients with BMI greater than or equal to 30 kg/m2 with greater than or equal to one comorbidities, or obese patients with BMI over 35 kg/m2. EndoBarrier is an incision-free, non-anatomy altering solution designed to specifically mimic the duodenal-jejunal exclusion created by gastric bypass surgery.