C. R. Bard, Inc. (Bard), a company developing products for vascular, urology, oncology, and surgical specialty markets, is planning to complete Phase I TRIM trial for RESTORe Suturing System by November 2010. The aim of the study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System. The trial is being conducted in US.
This non-randomized, open label, active control, single group assignment, safety/efficacy study is ongoing, but not recruiting participants. The study has estimated enrollment of 20 participants.
RESTORe Suturing System (RS2) is a next-generation endoscopic suturing device designed for primary weight loss. It is used for Transoral Gastric Volume Reduction (TGVR) for weight management for Class II or low grade class III Obesity.
The official title of the trial is “Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity.”