Taking people in United StatesNo phase
Testing a modified sleeve gastrectomy to reduce reflux after weight-loss surgery
Compares a modified stomach-reduction surgery with the standard one in adults with obesity.
Key facts
- Who runs it
- University of California, Irvine
- Where
- Orange and San Diego, United StatesSee the 2 sites
- Trial code
- Registry title
- Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
- Status
- Recruiting
- People taking part
- 44 people, planned
- Started
- 21 Mar 2025
- Expected to end
- 1 Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Modified Vertical Sleeve Gastrectomy (mVSG)
- Conventional Vertical Sleeve Gastrectomy (cVSG)
- Record updated
- 14 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity and acid reflux (GERD) who are planning a sleeve gastrectomy. It tests a modified type of this weight-loss surgery.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- Body mass index (BMI) 35-55 kg/m2, before and after 6 months of non-surgical weight management. Proven GERD.
- Earlier treatment
- Must have done 6 months of non-surgical weight management. No previous weight-loss (bariatric) or anti-reflux surgery.
- Biomarker or test result
- Acid exposure time (AET) of 4.9% or above on the Bravo pH test.
Main reasons for not taking part
- Hiatal hernia larger than 2cm (0.8 in)
- Barrett's esophagus
- Previous bariatric or anti-reflux surgery
- Pregnant, breastfeeding, or planning pregnancy in the next 24 months
- Alcohol or substance use disorder within the past year
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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 take part
- 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)
- Previous bariatric or anti-reflux procedure
- Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
- Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
- Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
- Portal hypertension or cirrhosis
- Active cancer treatment
- 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
- 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
- Severe gastroparesis
- Barrett's esophagus
- Subjects requiring mesh treatment at time of procedure
- Subjects with pacemakers, implantable defibrillators, neurostimulators
- Chronic pancreatitis
- Inability to tolerate general anesthesia
- Uncontrollable coagulopathy
- Pregnant or breastfeeding or planning pregnancy in the coming 24 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- University of California IrvineOrange, United StatesContact: Ninh T. Nguyen, MDTaking people
- University of California San DiegoSan Diego, United StatesContact: Ravinder K. Mittal, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Modified Vertical Sleeve Gastrectomy (mVSG)Treatment being tested
modified investigational vertical sleeve gastrectomy (mVSG)
- Conventional Vertical Sleeve Gastrectomy (cVSG)Existing treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
- Plain-language title
- Testing a modified sleeve gastrectomy to reduce reflux after weight-loss surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06783751, who can take part
- Record updated
- 14 July 2026