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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06783751
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified Vertical Sleeve Gastrectomy (mVSG) — PROCEDURE
    The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
  • Conventional Vertical Sleeve Gastrectomy (cVSG) — PROCEDURE
    Vertical Sleeve Gastrectomy as standard procedure

Study Details

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.

Key Dates

Start date
Mar 21, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Modified Vertical Sleeve Gastrectomy (mVSG)
    modified investigational vertical sleeve gastrectomy (mVSG)
  • Active Comparator: Conventional Vertical Sleeve Gastrectomy (cVSG)
    conventional vertical sleeve gastrectomy (cVSG)

Primary Outcome Measure

% Acid Exposure Time (%AET) [ Time Frame: Pre-surgery, Month 6-9 post surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92628
Ninh T. Nguyen, MD
[email protected]
714-456-8598
Cesar Figuerosa, BS
[email protected]
714.790.8536
University of California, San DiegoSan DiegoCalifornia92093
Ravinder K. Mittal, MD
[email protected]
858-534-3328

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