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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07453433
Eligibility Criteria:
Inclusion Criteria:
1. age ≥ 18 years;
2. histologically proven early gastric adenocarcinoma;
3. meeting the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2021 ;
4. Eastern Cooperative Oncology Group performance status ≤ 2;
5. adequate hematological function (hemoglobin ≥ 9 g/dL, platelets ≥ 50 000/mm3#international normalized ratio#1.5);
6. sufficient renal function (serum creatinine ≤ 2.0 mg/dL); and (7) adequate hepatic function (serum aspartate aminotransferase ≤ 100 IU/ L, serum alanine aminotransferase ≤ 100 IU/L).
Exclusion Criteria:
1. pregnancy or breastfeeding;
2. difficulty obtaining consent due to psychiatric disorder;
3. multiple lesions;
4. history of gastrectomy or gastrointestinal reconstruction surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07453433
Study Brief:
Protocol Section:
NCT07453433