BaroSense Inc. (BaroSense), a medical device company developing product for obesity, is planning to complete the trial entitled “Multi-Center Feasibility Study to Evaluate the Safety of the Trans-Oral Endoscopic Restrictive Implant System (TERIS) for the Treatment of Obesity” for Trans-oral Endoscopic Restrictive Implant System (TERIS) by May 2010. The primary purpose of the study is to evaluate the safety of TERIS procedure for the treatment of obesity over a six month follow-up period. The secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS procedure in order to guide the design of future studies, including a pivotal trial. The trial is being conducted in Canada with an estimated enrollment of 20 participants.
This randomized, open label, uncontrolled, single group assignment, safety study is ongoing, but not recruiting participants. The trial will involve patients who are obese and have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 20 subjects appropriate for trans-oral implant. The data from this study will be used in support of subsequent investigational studies, including a pivotal trial. The study director of the trial is Kathy Stecco, MD Medical Consultant.
TERIS is a safe, simple, effective, and minimally invasive alternative to the surgical treatment of obesity. It uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety.