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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03169569
Eligibility Criteria:
Inclusion Criteria:
* Older than 19 years old and younger than 85 years old
* Pathologically confirmed gastric adenoma and/or early gastric cancer
* Iatrogenic gastric ulcer after ESD (Endoscopic submucosal dissection) more than 40mm (at prediction)
* Patients who is taking antithrombotic drug such as aspirin and/or coumadin (and other anti-coagulation medication)
* ECOG performance status 0 or 1
* Adequate renal function (serum creatinine \< 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
* Adequate liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
* Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
* Subjects who given written informed consent after being given a full description of the study
Exclusion Criteria:
* Previously treated by radical gastrectomy
* Adverse effect on this medication
* Pregnant or on breast feeding
* Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT03169569
Study Brief:
Protocol Section:
NCT03169569