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NCT03406975 · ClinicalTrials.gov registry record · NA
Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 208
- Enrollment target
NCT03406975: Completed NA study, sponsored by Mayo Clinic.
NCT03406975 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 208 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03406975, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)
Interventions
- BEHAVIORAL Lifestyle Intervention
- DEVICE Overstitch Endoscopic Suture System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2021-10-15 |
| Phase | NA |
What the finished NCT03406975 record still lists
NCT03406975 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Lifestyle Intervention is the first listed.
NCT03406975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03406975 about?
NCT03406975 is a clinical study titled "Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)". 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 re...
What is the current status of trial NCT03406975?
This trial is currently completed. It is a NA study. The enrollment target is 208 participants. The study started on 2017-12-20. Estimated completion is 2021-10-15.
What interventions are being tested in trial NCT03406975?
The interventions under investigation include: Lifestyle Intervention (BEHAVIORAL), Overstitch Endoscopic Suture System (DEVICE).
Who is sponsoring clinical trial NCT03406975?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03406975's enrollment target sits among peer trials
208 496th of 2000 higher than 1,502 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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