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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT05507151
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
* Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
* Patients older than 18 years and younger than 75 years of age at the time of consent
* Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
* Patients willing and able to comply with study requirements for follow-up
Exclusion criteria:
* Patients who are treated with intragastric balloons
* Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration,
* Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
* Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia),
* Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation
* Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy
* Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease
* Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer \>1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency,
* Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent.
* The patient refuses or is unable to provide written informed consent
* Prior bariatric treatment procedure
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05507151
Study Brief:
Protocol Section:
NCT05507151