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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01475266
Eligibility Criteria:
Inclusion Criteria:
1. Patients who have provided written informed consent
2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:
* The maximum number of tumors is 5.
* Each tumor diameter: ≤ 3.5 cm.
3. Age: ≥20 years old at enrollment.
4. The functions of the major organs are adequate, and the following test value criteria are satisfied:
* Neutrophil count ≥1,500/μL
* Platelet count ≥10×10\^4/μL
* Hemoglobin ≥10 g/dL
Exclusion Criteria:
1. Patients with a single, primary bladder cancer of \<0.5 cm.
2. Patients with CIS lesions in the bladder or a history thereof.
3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
7. Patients who had been administered EO9 in the past.
8. Patients who had been administered any other investigational drug within the past 30 days.
9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01475266
Study Brief:
Protocol Section:
NCT01475266