Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-24 @ 12:13 PM
NCT ID:
NCT04166461
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory male or female (non-pregnant) and is 18-80 years old at the time of enrollment.
* Adults with BMI 35 ≥ kg/m2
* Patients scheduled for sleeve gastrectomy
* Patients with no presence of esophagitis on screening upper endoscopy will be recruited to pursue 6mo- post-op upper endoscopy.
Exclusion Criteria:
* Age \< 18 or \> 80 years old
* Female patients cannot be pregnant or agree to avoid pregnancy during study period.
* History of GERD, erosive esophagitis, esophageal stricture, Barrett's esophagus or esophageal varices
* History of a major motility disorder: achalasia, diffuse esophageal spasm, jackhammer esophagus, esophagogastric junction outflow obstruction, and absent peristalsis.
* History of Eosinophilic Esophagitis
* History of bariatric surgery or other upper gastrointestinal surgery
* History of Scleroderma
* PPI use prior to bariatric procedure
* History of severe psychiatric disorder, including suicidal ideation or admission to psychiatric institution.
* Negative upper endoscopy during pre-LSG evaluation for esophagitis, Barrett's esophagus, peptic stricture or eosinophilic esophagitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04166461
Study Brief:
Protocol Section:
NCT04166461