Bladder EpiCheck Product Development Study

This is a prospective, observational study to support the development of the Bladder EpiCheck kit by collecting urine samples from subjects suspected to have a bladder tumor or under NMIBC surveillance. This is a single visit study. Each subject will sign the informed consent and provide voided urine sample. Demography and, if performed, pathology information will be collected for each subject.

NCT Number	NCT07514143
Lead Sponsor	Nucleix Ltd.
Conditions	Suspicion of Bladder Cancer, NMIBC Surveillance
Enrollment	1,000 participants
Start Date	2025-09-15
Primary Completion	2026-11 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-07