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Bladder EpiCheck Product Development Study

Bladder EpiCheck Product Development Study

Recruiting
22 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Age 22 or older
  2. Willing and able to sign the informed consent form
  3. Subject(s) that is planned to undergo ,within 60 days, one of the following procedures:

3.1 TURBT due to suspected or detected bladder tumor, or 3.2 Cystoscopy under general anesthesia due to suspected bladder tumor, or 3.3 Cystoscopy for NMIBC surveillance

Exclusion Criteria:

  1. Patients with known or history of muscle invasive bladder cancer (MIBC)
  2. Treatment of prostate cancer or RCC in the past 2 years
  3. Patients previously enrolled into this study within the prior 60 days

Study details
    Suspicion of Bladder Cancer
    NMIBC Surveillance

NCT07514143

Nucleix Ltd.

13 May 2026

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