Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
Public ClinicalTrials.gov record NCT03406975. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03406975
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Interventions
- Overstitch Endoscopic Suture System Device
- Lifestyle Intervention Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 19, 2017
- Primary completion
- Oct 28, 2020
- Completion
- Oct 14, 2021
- Last update posted
- Oct 17, 2022
2017 – 2021
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orlando Health | Orlando | Florida | 32806 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Cornell University | New York | New York | 10065 | — |
| Avera McKennan Hospital & University Health Center | Sioux Falls | South Dakota | 57105 | — |
| University of Texas | Houston | Texas | 77401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03406975, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 17, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03406975 live on ClinicalTrials.gov.