NCT06783751 · University of California, Irvine
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
(INNOVATE-VSG)
What this study is about
This is a two-site randomly assigned clinical trial aiming to test whether a modified experimental bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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.
Where
- Orange, California
- San Diego, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations