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:
NCT04006002
Eligibility Criteria:
Inclusion Criteria:
1. BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention
2. Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.
3. Both male and female subjects will be included in the study.
4. Subjects from any ethnic background will be included in the study.
5. Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).
6. Successfully complete the screening process.
7. Patients able to provide written informed consent on the IRB/EC-approved informed consent form.
8. Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.
9. Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.
Exclusion Criteria:
1. Pregnant or planning to become pregnant during period of study participation.
2. Female participants who are breast-feeding.
3. Severe Immunodeficiency.
4. Severe malnutrition.
5. The participant has life expectancy of less than 1 year due to other medical conditions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04006002
Study Brief:
Protocol Section:
NCT04006002