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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04880902
Eligibility Criteria:
Inclusion Criteria:
* BMI of \> 40 kg/m 2 or \> 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.
* All patients failed in supervised conservative management for obesity for at least 2 years.
Exclusion Criteria:
* BMI \> 60
* previous bariatric surgery
* symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)
* Significant psychological disorder, active alcohol or substance abuse
* severe eating disorders (bulimia)
* severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04880902
Study Brief:
Protocol Section:
NCT04880902