Actively Recruiting
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
Led by University of California, Irvine · Updated on 2026-04-13
44
Participants Needed
2
Research Sites
123 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
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.
CONDITIONS
Official 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) 35-55 kg/m2
- Must meet BMI criteria before and after 6 months of nonsurgical weight management
- Presence of GERD defined as acid exposure time (AET) of 4.9% or above by Bravo pH test
- Have health insurance covering bariatric surgery and standard medical care before and after surgery
- Women of childbearing potential must use contraception and have negative pregnancy tests at entry and before surgery
- Must be able to provide written informed consent
You will not qualify if you...
- Hiatal hernia larger than 2 cm as measured by imaging or surgery
- Major esophageal motility disorder as determined by investigator
- 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 blood clotting disorders
- Significant uncontrolled inflammatory bowel disease
- Severe or uncontrolled psychiatric disorders including psychosis or bipolar disorder
- Suicidal thoughts or untreated major depression in the past year
- Alcohol or substance use disorder in the past year
- Pregnant, breastfeeding, or planning pregnancy within 24 months
- Reduced intellectual ability to consent or follow study instructions
- Any current or past health condition making surgery unsafe or participation risky as judged by investigator
AI-Screening
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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
CONTACT
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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