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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01614418
Eligibility Criteria:
Inclusion Criteria:
1. Histological confirmation of gastric IM or dysplasia.
2. The lesion is no larger than 5 cm in diameter.
3. Age ≥ 18 years.
4. No previous endoscopic mucosal resection or submucosal dissection.
5. No active H. pylori infection.
6. Subject is able to tolerate endoscopy and sedation.
7. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.
Exclusion Criteria:
1. Gastric cancer (intra-mucosal cancer or worse).
2. Prior gastric irradiation or surgery.
3. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
4. Gastric ulcers, fistulae and varices.
5. History of alcohol and/or controlled substance dependency.
6. Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01614418
Study Brief:
Protocol Section:
NCT01614418