Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
Recruiting
N/A
Interventional Study
Obesity
Bariatric Surgery
Sleeve Gastrectomy
Gastroesophageal Reflux Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 44 (estimated)
- Sponsor
- University of California, Irvine · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
Contacts