Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated Wi… (NCT06783751) | Clinical Trial Compass
RecruitingNot Applicable
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
United States44 participantsStarted 2025-03-21
Plain-language summary
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
Age range18 Years – 65 Years
SexALL
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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
. 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