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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT03776669
Eligibility Criteria:
Inclusion Criteria:
* Patients with:
1. Body mass index (BMI) ≧ 35, or
2. 30 ≦ BMI \< 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or
3. T2DM with BMI ≧ 32.5, or
4. T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially for those with major cardiovascular risk.
* Age: 20 to 65 years old.
* Hiatal hernia diagnosed by either:
1. HRIM: defined as the distance between low esophageal sphincter (LES) and crural diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm)
2. EGD: defined as the apparent separation between the squamocolumnar junction and the diaphragmatic impression is greater than 2 cm.
Exclusion Criteria:
* Prior major gastrointestinal (GI) tract surgery.
* Bleeding tendency.
* American Society of Anesthesiologists physical status (ASA) ≧ class III.
* Pregnancy or lactating women.
* Allergy to contrast medium for CT scan.
* Concomitantly untreated or uncontrolled endocrine disease.
* Alcohol or drug abuse.
* Mental, behavioral, and neurodevelopmental disorders.
1. Patients who possess "National Health Insurance (NHI) Major Illness/Injury Certificate" for ICD-10-CM codes F01-F99. (ICD: International Classification of Diseases; CM: Clinical Modification)
2. Patients who have been hospitalized in psychiatric ward in the recent one year.
* Type IV hiatal hernia.
* Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to medical treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03776669
Study Brief:
Protocol Section:
NCT03776669