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

Obesity Clinical Trial

Official title:
Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

Clinical 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03406975
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase N/A
Start date December 20, 2017
Completion date October 15, 2021
View Details
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