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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Gastroesophageal Reflux Disease; Bariatric Surgery; Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Modified Vertical Sleeve Gastrectomy (mVSG); Procedure: Conventional Vertical Sleeve Gastrectomy (cVSG)

Detailed Description

The study will examine whether a modified vertical sleeve gastrectomy (mVSG) will improve GERD and quality of life.

Aim 1 (Primary): to determine whether mVSG, in comparison to conventional vertical sleeve gastrectomy (cVSG), will be associated with lower acid exposure time (AET, measured by the Bravo pH test) at 6-9 months. The investigators hypothesize that, at Month 6-9, compared to cVSG:

• H1. mVSG will be associated with lower AET

Aim 2 (Secondary): To elucidate the mechanistic basis for Aim 1, the investigators will perform following tests, before and at 6-9 months post-surgery: a) High resolution esophageal manometry (HREM) to determine the lower esophageal sphincter (LES) and intragastric pressure; b) The endoluminal functional lumen imaging probe (EndoFLIP) testing to examine changes in compliance of the LES; c) Measure the length of the gastroesophageal flap valve (GEFV) on the retroflex view during endoscopic exam. The investigators hypothesize that, at Month 6-9, compared to cVSG:

• H2a. mVSG will be associated with higher LES pressure and lower intragastric pressure
• H2b. mVSG will be associated with lower LES compliance
• H2c. GEFV will be present after mVSG (vs absence after cVSG)

Aim 3: Examine the impact of GERD on quality of life (QoL) with two validated rating scales - Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) and Short Form-36 (SF-36). The investigators hypothesize that, at 12 months, compared to cVSG:

• H3. mVSG will lead to superior QoL

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ninh T. Nguyen, MD; Phone Number: 714 456 8598; Email: ninhn@hs.uci.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92628
      • Recruiting
      • University of California, Irvine
      • Contact: Ninh T. Nguyen, MD; Phone Number: 714-456-8598; Email: ninhn@hs.uci.edu
      • Contact: Cesar Figuerosa, BS; Phone Number: 714.790.8536; Email: figuerc1@hs.uci.edu
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Ravinder K. Mittal, MD; Phone Number: 858-534-3328; Email: rmittal@ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female subjects aged 18-65 years
2. Body mass index (BMI) 35-55 kg/m2
3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management
4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
6. 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
7. Must be able to provide written informed consent

Exclusion Criteria:

1. 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)
2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
3. Severe gastroparesis
4. Previous bariatric or anti-reflux procedure
5. Barrett's esophagus
6. Subjects requiring mesh treatment at time of procedure
7. Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
8. Subjects with pacemakers, implantable defibrillators, neurostimulators
9. Portal hypertension or cirrhosis
10. Chronic pancreatitis
11. Active cancer treatment
12. Inability to tolerate general anesthesia
13. Uncontrollable coagulopathy
14. Significant and uncontrolled inflammatory bowel disease
15. Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
16. Suicidal ideation or unstable/untreated major depressive disorder within the past year
17. Alcohol or substance use disorder within the past year.
18. Pregnant or breastfeeding or planning pregnancy in the coming 24 months
19. Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
20. History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Vertical Sleeve Gastrectomy (mVSG); modified investigational vertical sleeve gastrectomy (mVSG)	Procedure: Modified Vertical Sleeve Gastrectomy (mVSG); The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
Active Comparator: Conventional Vertical Sleeve Gastrectomy (cVSG); conventional vertical sleeve gastrectomy (cVSG)	Procedure: Conventional Vertical Sleeve Gastrectomy (cVSG); Vertical Sleeve Gastrectomy as standard procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
LES pressure	Change in LES pressure in millimeters of mercury (mmHg) assessed with High Resolution Esophageal Manometry (HREM)	Pre-surgery, Month 6-9 post surgery
Intragastric pressure	Change in intragastric pressure in millimeters of mercury (mmHg) assessed with HREM	Pre-surgery, Month 6-9 post surgery
LES compliance	Change in LES compliance in ratio of mm3/mmHg assessed with EndoFLIP	Pre-surgery, Month 6-9 post surgery
GEFV length	Change in GEFV length in millimeters (mm) assessed with endoscopic exam	Pre-surgery, Month 6-9 post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GERD-HRQL score	Change in GERD-HRQL score assessed with GERD-HRQL questionnaire	Pre-surgery, Months 4, 6-9, 12 post surgery
Health-related quality of life	Change in SF-36 score assessed with SF-36 questionnaire	Pre-surgery, Months 4, 6-9, 12 post surgery

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of California, San Diego
• Investigators: Principal Investigator: Ninh T. Nguyen, MD, University of California, Irvine; Principal Investigator: Ravinder K. Mittal, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Overweight; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Gastroesophageal Reflux
• Other Study ID Numbers: 3451; 1R01DK138047-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No