Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associ
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.
| Condition(s) | Obesity, Bariatric Surgery, Sleeve Gastrectomy, Gastroesophageal Reflux Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Male and female subjects aged 18-65 years 2. Body mass index (BMI) 35-55 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 a |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of California, Irvine |
| Locations | Orange, California, United States; San Diego, California, United States |
| Start date | 2025-03-21 |
| NCT ID | NCT06783751 |
| Official listing | https://clinicaltrials.gov/study/NCT06783751 |