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

NCT06783751 | Recruiting DMC

• 2 other identifiers: 34511R01DK138047-01A1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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; Sleeve Gastrectomy; Gastroesophageal Reflux Disease; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• % Acid Exposure Time (%AET)

  Change in %AET in percentage points at Month 6-9 relative to pre-surgery %AET assessed with the Bravo pH test

  Pre-surgery, Month 6-9 post surgery

Secondary Outcomes (4)

• LES pressure

  Pre-surgery, Month 6-9 post surgery

• Intragastric pressure

  Pre-surgery, Month 6-9 post surgery

• LES compliance

  Pre-surgery, Month 6-9 post surgery

• GEFV length

  Pre-surgery, Month 6-9 post surgery

Other Outcomes (2)

• GERD-HRQL score

  Pre-surgery, Months 4, 6-9, 12 post surgery

• Health-related quality of life

  Pre-surgery, Months 4, 6-9, 12 post surgery

Study Arms (2)

Modified Vertical Sleeve Gastrectomy (mVSG)

EXPERIMENTAL

modified investigational vertical sleeve gastrectomy (mVSG)

Procedure: Modified Vertical Sleeve Gastrectomy (mVSG)

Conventional Vertical Sleeve Gastrectomy (cVSG)

ACTIVE COMPARATOR

conventional vertical sleeve gastrectomy (cVSG)

Procedure: Conventional Vertical Sleeve Gastrectomy (cVSG)

Interventions

Modified Vertical Sleeve Gastrectomy (mVSG) PROCEDURE

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

Modified Vertical Sleeve Gastrectomy (mVSG)

Conventional Vertical Sleeve Gastrectomy (cVSG) PROCEDURE

Vertical Sleeve Gastrectomy as standard procedure

Conventional Vertical Sleeve Gastrectomy (cVSG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18-65 years
• Body mass index (BMI) 35-55 kg/m2
• Must meet the BMI criteria before and after 6 months of nonsurgical weight management
• Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
• Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
• Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery
• Must be able to provide written informed consent

You may not qualify if:

• Hiatal hernia \>2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)
• Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
• Severe gastroparesis
• Previous bariatric or anti-reflux procedure
• Barrett's esophagus
• Subjects requiring mesh treatment at time of procedure
• Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
• Subjects with pacemakers, implantable defibrillators, neurostimulators
• Portal hypertension or cirrhosis
• Chronic pancreatitis
• Active cancer treatment
• Inability to tolerate general anesthesia
• Uncontrollable coagulopathy
• Significant and uncontrolled inflammatory bowel disease
• Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, San Diego: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of California, Irvine

Orange, California, 92628, United States

RECRUITING

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ninh T. Nguyen, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Ravinder K. Mittal, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ninh T. Nguyen, MD

CONTACT

714 456 8598; ninhn@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 20, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)