Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)

Summary

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction.

Up to 200 participants at 9 locations in the United States will participate in this study.

The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.

Conditions

• Obesity
• Hypertension
• Diabetes Mellitus, Type 2

Interventions

DEVICE

Overstitch Endoscopic Suture System

Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.

BEHAVIORAL

Lifestyle Intervention

Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.

Sponsors & Collaborators

• University of Texas

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Endeavor Health

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Orlando Health, Inc.

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Avera McKennan Hospital & University Health Center

  collaborator OTHER

• Mayo Clinic

  lead OTHER

Principal Investigators

• Barham K Abu Dayyeh · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-12-20

Primary Completion

2020-10-29

Completion

2021-10-15

FDA Device

Yes

Countries

• United States

Study Locations