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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03255005
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18-65 years;
2. Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;
6. Had followed the bariatric multidisciplinary workup (blood analyses, dietician, psychologist and doctor appointments).
Exclusion Criteria:
1. Achalasia and any other esophageal motility disorders;
2. Severe esophagitis;
3. Gastro-duodenal ulcer;
4. Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
5. Hypertension: uncontrolled hypertension during last 3 months;
6. Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
7. TBWL \>5% over the last 6 months;
8. Severe renal, hepatic, pulmonary disease or cancer;
9. GI stenosis or obstruction;
10. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
11. Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;
12. Anticoagulant therapy;
13. Impending gastric surgery 60 days post intervention;
14. Currently participating in other study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03255005
Study Brief:
Protocol Section:
NCT03255005