ReShape Vest™ for the Treatment of Obesity (Europe)

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2021

Conditions
ObesityWeight Loss
Interventions
DEVICE

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)."

Trial Locations (1)

Unknown

RECRUITING

Hospital universitario de Bellvitge, Barcelona

Sponsors
All Listed Sponsors
lead

ReShape Lifesciences

INDUSTRY