Actively Recruiting
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
Led by University of California, Irvine · Updated on 2026-04-13
44
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a new type of vertical sleeve gastrectomy surgery, called modified vertical sleeve gastrectomy (mVSG), can reduce gastroesophageal reflux disease (GERD) after sleeve gastrectomy. This randomized clinical trial compares mVSG with the conventional vertical sleeve gastrectomy (cVSG) to see if mVSG lowers acid exposure in the esophagus and improves quality of life. The study aims to understand the surgical effects and mechanisms behind GERD improvement in people with obesity and related conditions. Participants will be randomly assigned to receive either the modified vertical sleeve gastrectomy, which preserves certain stomach fibers and restores the gastroesophageal flap valve, or the conventional sleeve gastrectomy as a standard procedure. The study will assess outcomes before surgery and again 6 to 9 months after surgery. Tests include monitoring acid exposure using the Bravo pH test, measuring pressures in the esophagus and stomach, and evaluating the presence of the flap valve during endoscopy. During the study, participants will undergo various exams such as esophageal manometry and endoscopic imaging both before surgery and at follow-up visits between 6 and 9 months later. Researchers will also assess quality of life related to GERD at 12 months using validated questionnaires. The trial will monitor safety and the effects of surgery on symptoms and physiology, with participation lasting through at least one year after surgery.
CONDITIONS
Brief Title
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-65 years
- Body mass index (BMI) between 35 and 55 kg/m2
- Must meet BMI criteria before and after 6 months of nonsurgical weight management
- GERD defined as acid exposure time (AET) of 4.9% or above on Bravo pH test
- Health insurance covering bariatric surgery and standard care before and after surgery
- Women of childbearing potential must use contraception and have a negative pregnancy test before surgery
- Ability to provide written informed consent
You will not qualify if you...
- Hiatal hernia larger than 2 cm
- Major esophageal motility disorder
- Severe gastroparesis
- Previous bariatric or anti-reflux surgery
- Barrett's esophagus
- Need for mesh treatment during procedure
- Severe heart or end-stage lung disease
- Presence of pacemakers, defibrillators, or neurostimulators
- Portal hypertension or cirrhosis
- Chronic pancreatitis
- Active cancer treatment
- Inability to tolerate general anesthesia
- Uncontrollable bleeding disorders
- Significant uncontrolled inflammatory bowel disease
- Severe or uncontrolled psychiatric disorders
- Suicidal thoughts or untreated major depression in past year
- Alcohol or substance use disorder in past year
- Pregnant, breastfeeding, or planning pregnancy in next 24 months
- Reduced ability to consent or follow instructions
- Any health condition making sleeve gastrectomy risky or unsuitable per investigator judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo either the modified vertical sleeve gastrectomy (mVSG) or the conventional vertical sleeve gastrectomy (cVSG) surgery.
1 surgical visit and immediate post-operative care
Duration - 6 to 9 months
Participants have assessments including Bravo pH test, high resolution esophageal manometry (HREM), EndoFLIP testing, and endoscopic exam before surgery and at 6 to 9 months after surgery to evaluate acid exposure and esophageal function.
2 visits (pre-surgery and 6 to 9 months post-surgery)
Duration - Up to 12 months
Participants complete quality of life assessments to examine the impact of GERD at 12 months after surgery.
1 visit at 12 months post-surgery
Trial Site Locations
Total: 2 locations
1
University of California, Irvine
Orange, California, United States, 92628
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
N
Ninh T. Nguyen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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