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A volunteer subject with no known significant health problems who participates in research to test a new drug, device or intervention. These volunteers are recruited to serve as controls for patient groups. Healthy volunteers receive the same test, procedure, or drug the patient group receives.

Search Results 1-1 of 1 for Endoscopic sleeve gastroplasty

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  • Study status: Open/Status Unknown
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  1. Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

    Rochester, MN

    Multi-center ESG Randomized Interventional Trial (MERIT-Trial)

    • Location:

      Interventional What is this?

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    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 endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We 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

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

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    Study IDs

    • Site IRB:

      • Rochester, Minnesota: 17-007934

    • NCT ID:

      NCT03406975

    • Sponsor Protocol Number:

      17-007934
.

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