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ObesityINNOVATE-VSGNCT06783751

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

A study testing Modified Vertical Sleeve Gastrectomy (mVSG) and Conventional Vertical Sleeve Gastrectomy (cVSG) in people with Obesity and Bariatric Surgery, run by University of California, Irvine at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Bariatric Surgery, Sleeve Gastrectomy
What is being tested?
Modified Vertical Sleeve Gastrectomy (mVSG) and Conventional Vertical Sleeve Gastrectomy (cVSG)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesUnited States
Study dates
21 Mar 2025to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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.
  • Suicidal ideation or unstable/untreated major depressive disorder within the past year
  • Alcohol or substance use disorder within the past year.
  • Pregnant or breastfeeding or planning pregnancy in the coming 24 months
  • Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ninh T. Nguyen, MD contact

714 456 8598

ninhn@hs.uci.edu

United States2 sites, 2 recruiting

  • University of California, Irvine

    Orange, California, 92628

    Ninh T. Nguyen, MD, 714-456-8598, ninhn@hs.uci.edu

    Cesar Figuerosa, BS, 714.790.8536, figuerc1@hs.uci.edu

    Recruiting

  • University of California, San Diego

    San Diego, California, 92093

    Ravinder K. Mittal, MD, 858-534-3328, rmittal@ucsd.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Modified Vertical Sleeve Gastrectomy (mVSG), Conventional Vertical Sleeve Gastrectomy (cVSG)
Medical subject headings
Obesity, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Vertical Sleeve Gastrectomy (mVSG)Procedure or surgery

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

  • Conventional Vertical Sleeve Gastrectomy (cVSG)Procedure or surgery

    Vertical Sleeve Gastrectomy as standard procedure

Study groups in NCT06783751
Study groupRoleWhat they receive
Modified Vertical Sleeve Gastrectomy (mVSG)Experimentalmodified investigational vertical sleeve gastrectomy (mVSG)
Receives: Procedure: Modified Vertical Sleeve Gastrectomy (mVSG)
Conventional Vertical Sleeve Gastrectomy (cVSG)Active comparatorconventional vertical sleeve gastrectomy (cVSG)
Receives: Procedure: Conventional Vertical Sleeve Gastrectomy (cVSG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Pre-surgery, Month 6-9 post surgery

Secondary outcomes (4)

  1. LES pressure

    Change in LES pressure in millimeters of mercury (mmHg) assessed with High Resolution Esophageal Manometry (HREM)

    Measured: Pre-surgery, Month 6-9 post surgery

  2. Intragastric pressure

    Change in intragastric pressure in millimeters of mercury (mmHg) assessed with HREM

    Measured: Pre-surgery, Month 6-9 post surgery

  3. LES compliance

    Change in LES compliance in ratio of mm3/mmHg assessed with EndoFLIP

    Measured: Pre-surgery, Month 6-9 post surgery

  4. GEFV length

    Change in GEFV length in millimeters (mm) assessed with endoscopic exam

    Measured: Pre-surgery, Month 6-9 post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start21 Mar 2025
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06783751
Sponsor's protocol ID
3451
Other IDs
1R01DK138047-01A1
Acronym
INNOVATE-VSG
Status last verified
Jul 2026
First submitted
2 Jan 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified Vertical Sleeve Gastrectomy (mVSG) and Conventional Vertical Sleeve Gastrectomy (cVSG) in people with Obesity and Bariatric Surgery, run by University of California, Irvine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ninh T. Nguyen, MD (714 456 8598, ninhn@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% Acid Exposure Time (%AET) (time frame: Pre-surgery, Month 6-9 post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06783751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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