MedTrace Logo

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

NCT06783751 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Obesity
  • Bariatric Surgery
  • Sleeve Gastrectomy
  • Gastroesophageal Reflux Disease

Interventions

PROCEDURE

Modified Vertical Sleeve Gastrectomy (mVSG)

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

PROCEDURE

Conventional Vertical Sleeve Gastrectomy (cVSG)

Vertical Sleeve Gastrectomy as standard procedure

Sponsors & Collaborators

  • University of California, San Diego

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Ninh T. Nguyen, MD · University of California, Irvine

  • Ravinder K. Mittal, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06783751 on ClinicalTrials.gov