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

Prior treatment

• 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

Other illness

• 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.

Other

• 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

• 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