65
Participants
Start Date
March 25, 2019
Primary Completion Date
December 31, 2020
Study Completion Date
December 31, 2021
Laparoscopic Gastric Vest (LGV)
"The Laparoscopic Gastric Vest (LGV), branded the ReShape Vest™, is a long-term, silastic, implantable system that is placed around the stomach to encompass the gastroesophageal junction to the Incisura Angularis.~The main materials used to make the LGV is Implant Grade Silicone (95%) and Barium Sulfate (5%).~The LGV is indicated for weight reduction for obese people with a Body Mass Index (BMI) between ≥35 kg/m2 and ≤55 kg/m2. It is indicated for use in adult patients (≥22 to ≤65 years) who have failed one or more conservative weight reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s)."
RECRUITING
Hospital universitario de Bellvitge, Barcelona
Lead Sponsor
ReShape Lifesciences
INDUSTRY