Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)
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.
• 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