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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03406975
The ClinicalTrials.gov registry entry for NCT03406975 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lifestyle Intervention is the first listed.
NCT03406975 reports 0 study locations.
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.
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