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:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT04422405
Eligibility Criteria:
Inclusion Criteria:
* BMI\> 35 kg/m2
* 2 years of controlled conservative obesity treatment without weight reduction
* patients should give their consent to participate in the study
Exclusion Criteria:
* Less than 2 years of conservative obesity treatment
* cancer
* cirrhosis Child-Pough score A
* Crohn's disease
* serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
* drug consumption
* non-compliance
* hiatal hernia \> 4cm
* gastric pouch \< 10cm
* Barett esophagus
* erosive esophagitis Grade C or D according to the Los Angeles Classification
* endoscopically proven gastric stricture
* acid exposition time \> 6% (Lyon criteria)
* reflux episodes\> 80 /24 hours (Lyon criteria)
* insufficient low esophageal sphincter according to manometry findings
* pathological findings in the impedance pH-metry (acid and non-acid reflux)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04422405
Study Brief:
Protocol Section:
NCT04422405