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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT07019220
Eligibility Criteria:
Inclusion Criteria:
* Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study
* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening
* On screening cystoscopy: Diameter of the largest lesion ≤15mm
* Number of lesions ≤5
* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation
* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)
* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)
* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening
* No lymph node metastasis or distant metastasis
* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period
* Willing and able to provide informed consent
Exclusion Criteria:
* Tumors that clinicians suspect to be HG
* Positive HG cytology according to Paris criteria
* Diameter of tumor \>15 mm
* Number of lesions \>5
* Any previous intravesical therapy within 1 year
* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.
* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC
* History of upper tract urothelial carcinoma (UTUC)
* Clinically significant urethral stricture that would preclude passage of a urethral catheter
* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding
* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment
* Patient refused to participate
* Known positive human immunodeficiency virus (HIV) test.
* Female patients who are pregnant/breastfeeding.
* Female patients of childbearing potential not using adequate contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07019220
Study Brief:
Protocol Section:
NCT07019220