RecruitingNot ApplicableNCT06783751

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)


Sponsor

University of California, Irvine

Enrollment

44 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This two-site randomized trial tests whether a modified version of sleeve gastrectomy — a popular weight-loss surgery — can reduce acid reflux (GERD) compared to the standard surgical technique, which is known to worsen reflux in many patients. The modified procedure aims to preserve or recreate a natural valve at the lower end of the esophagus that prevents stomach acid from flowing upward. Adults aged 18–65 with a BMI of 35–55 kg/m², confirmed GERD (measured by a pH test), and health insurance covering bariatric surgery who have not had prior weight-loss or anti-reflux surgery may be eligible. Participation involves the assigned surgical procedure followed by measurement tests (pH monitoring, manometry, endoscopy) and quality-of-life questionnaires at 6–9 months and 12 months post-surgery. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREModified Vertical Sleeve Gastrectomy (mVSG)

The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).

PROCEDUREConventional Vertical Sleeve Gastrectomy (cVSG)

Vertical Sleeve Gastrectomy as standard procedure


Locations(2)

University of California, Irvine

Orange, California, United States

University of California, San Diego

San Diego, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06783751


Related Trials