Trials / Recruiting
RecruitingNCT07514143
Bladder EpiCheck Product Development Study
Collection of Urine Samples to Support the Bladder EpiCheck Product Development Studies
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Nucleix Ltd. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Bladder EpiCheck | Methylation biomarker urine test |
Timeline
- Start date
- 2025-09-15
- Primary completion
- 2026-11-01
- Completion
- 2026-12-01
- First posted
- 2026-04-07
- Last updated
- 2026-04-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07514143. Inclusion in this directory is not an endorsement.