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

NCT ID: NCT06783751

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2027-07-31

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.

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

Conditions

Obesity; Bariatric Surgery; Sleeve Gastrectomy; Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Modified Vertical Sleeve Gastrectomy (mVSG)

modified investigational vertical sleeve gastrectomy (mVSG)

Group Type: EXPERIMENTAL

Modified Vertical Sleeve Gastrectomy (mVSG)

Intervention Type: PROCEDURE

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

Conventional Vertical Sleeve Gastrectomy (cVSG)

conventional vertical sleeve gastrectomy (cVSG)

Group Type: ACTIVE_COMPARATOR

Conventional Vertical Sleeve Gastrectomy (cVSG)

Intervention Type: PROCEDURE

Vertical Sleeve Gastrectomy as standard procedure

Interventions

Modified Vertical Sleeve Gastrectomy (mVSG)

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

Intervention Type: PROCEDURE

Conventional Vertical Sleeve Gastrectomy (cVSG)

Vertical Sleeve Gastrectomy as standard procedure

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Nihn Tuan Nguyen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ninh T. Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Ravinder K. Mittal, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

University of California, San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ninh T. Nguyen, MD

Role: CONTACT

ninhn@hs.uci.edu

714 456 8598

Facility Contacts

Ninh T. Nguyen, MD

Role: primary

ninhn@hs.uci.edu

714.456.8598

Cesar Figuerosa, BS

Role: backup

figuerc1@hs.uci.edu

714.790.8536

Ravinder K. Mittal, MD

Role: primary

rmittal@ucsd.edu

858-534-3328

Other Identifiers

1R01DK138047-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3451

Identifier Type: -

Identifier Source: org_study_id