NCT03918564

ReShape Vest™ for the Treatment of Obesity (Europe)

An Investigative, Prospective, Non-randomized, Multi-center Study to Assess the Safety and Effectiveness of a Novel Gastric Restrictive Device, Call the ReShape Vest™, in People Who Are Obese.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and effectiveness of the LGV in treating obese subjects with a BMI of 35 kg/m2 to 55 kg/m2 who have failed one or more conservative weight-reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s).

Conditions

• Obesity
• Weight Loss

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2019-04-17
• Last updated: 2020-02-24

Locations

1 site across 1 country: Spain