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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jan 14, 2025

Keywords

ClinConnect Summary

The INNOVATE-VSG trial is a study looking at a new type of surgery designed to help people with obesity who also suffer from gastroesophageal reflux disease (GERD) after undergoing a procedure called sleeve gastrectomy. GERD is a condition where stomach acid frequently flows back into the esophagus, causing discomfort. This trial will test whether this modified surgical technique can reduce GERD symptoms in participants. The study is currently recruiting individuals aged 18 to 60 who have a body mass index (BMI) between 35 and 50 and have been diagnosed with GERD.

To participate, individuals must meet certain criteria, such as having health insurance that covers bariatric surgery and being able to provide informed consent. Participants will undergo pre-surgery evaluations and will be monitored throughout the study to assess the surgery's effects on their GERD symptoms. It’s important to note that some people may be excluded from the trial due to specific health conditions, such as severe heart or lung disease. Overall, this study aims to provide valuable insights into improving the quality of life for those dealing with obesity and GERD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female subjects aged 18-60 years
• • 2. Body mass index (BMI) 35-50 kg/m2
• • 3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management
• • 4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
• • 5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
• • 6. 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
• • 7. Must be able to provide written informed consent
• Exclusion Criteria:
• • 1. 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)
• • 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
• • 3. Severe gastroparesis
• • 4. Previous bariatric or anti-reflux procedure
• • 5. Barrett's esophagus
• • 6. Subjects requiring mesh treatment at time of procedure
• • 7. Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
• • 8. Subjects with pacemakers, implantable defibrillators, neurostimulators
• • 9. Portal hypertension or cirrhosis
• • 10. Chronic pancreatitis
• • 11. Active cancer treatment
• • 12. Inability to tolerate general anesthesia
• • 13. Uncontrollable coagulopathy
• • 14. Significant and uncontrolled inflammatory bowel disease
• • 15. Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
• • 16. Suicidal ideation or unstable/untreated major depressive disorder within the past year
• • 17. Alcohol or substance use disorder within the past year.
• • 18. Pregnant or breastfeeding or planning pregnancy in the coming 24 months
• • 19. Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
• • 20. 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.