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:
NCT03348969
Eligibility Criteria:
Inclusion Criteria:
* Known history of urothelial non-invasive Ta-tumour low-grade or high-grade.
* ≥18 years old
* Mentally healthy individual
* The ability to understand Danish orally and in writing
Exclusion Criteria:
* Known history of invasive tumour of the bladder (T1+)
* Known history of CIS of the bladder
* Previous BCG-treatment within the last 24 months
* Previous Mitomycin C-treatment (except single-shot postoperative instillation)
* Known allergy or intolerance to Mitomycin C
* Solid tumour with suspicions of invasion
* Single tumour of more than 2 cm in diameter
* Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions).
* Small bladder volume (less than 100 ml) or incontinence
* Acute cystitis
* Pregnancy or breast-feeding
* Not willing to use secure contraception with regard to men with partners and premenopausal women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03348969
Study Brief:
Protocol Section:
NCT03348969