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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04152720
Eligibility Criteria:
Inclusion Criteria:
1. Between 19 and 80 years old
2. Persons requiring urethral catheterization for more than 2 weeks after surgery \* due to urological diseases
\* Radical cystectomy
3. Subjects who voluntarily decided to participate and signed the written informed consent
4. A person who can understand and follow the instructions and participate in the pre-clinical period.
Exclusion Criteria:
1. A person with a congenital abnormality in the urinary or reproductive system
2. Immunodeficiency disease (eg HIV infected)
3. Urinary tract fistula
4. Allergic history of the material used in the catheter
5. Symptomatic UTI by baseline time point
6. Dermatitis at the catheter insertion site
7. Pregnant or lactating women
8. A person who does not agree to contraceptive \* in a medically accepted manner until the end of the study and 4 weeks after the end of the study.
Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc.
9. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
10. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT04152720
Study Brief:
Protocol Section:
NCT04152720