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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03570034
Eligibility Criteria:
Inclusion Criteria:
* At least 22 years old
* BMI of 30-40 kg/m2
Exclusion Criteria:
* Contraindicated for the device
* Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
* Known history of endocrine disorders affecting weight.
* Participation in any clinical study which could affect weight loss within the past year
* Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
* Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03570034
Study Brief:
Protocol Section:
NCT03570034