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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT06245603
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 years of age
* ECOG PS 0-2
* Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.
* Patients candidate to BCG or MMC intravesical induction therapy.
* Transurethral resection (TURB/re-TURB when indicated) performed in the last 4 weeks.
* IPSS score ≤10
* Negative urine culture within 2 weeks before T0
* For women who are not postmenopausal (i.e., \< 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period
* Signed the study informed consent prior to any study specific procedures.
* Will and ability to comply with the protocol
Exclusion Criteria:
* Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue \> 150 ml;
* Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it.
* Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study
* Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.
* Urinary tract infection requiring antibiotics
* Have a known hypersensitivity to any substance present in the investigational device.
* Neurogenic bladder
* Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06245603
Study Brief:
Protocol Section:
NCT06245603