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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT02730533
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document.
* Female or male aged ≥18 years.
* Patients must have gastric mucosal lesion that are eligible for ESD indications (Japanese Gastric Cancer Association 2011), including early gastric cancer, polyps, adenoma, and precancerous/suspected lesions diagnosed by endoscopy.
Exclusion Criteria:
* Malignancy or other advanced disease with a life expectancy of \< 6 months as judged by the investigator.
* The ASA classification of physical status ≥ 4 as judged by the investigator.
* Severe hepatic disease or renal disease
* Ability to understand and the willingness to sign a written informed consent document.
* Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
* Haemorrhagic disorder.
* Patients who had a history of gastrectomy or a recurrent lesion.
* Known or suspected hypersensitivity to any component of any PPI .
* Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
* Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
* Known or suspected alcohol, drug or medication abuse.
* Any condition associated with poor compliance as judged by the investigator.
* Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
* Involvement in the planning and conduct of the study. Previous enrollment in the present study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02730533
Study Brief:
Protocol Section:
NCT02730533