Trials / Completed
CompletedNCT04720599
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Exosome Diagnostics, Inc. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- —
Summary
The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ExoDx Prostate(IntelliScore) | The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2021-01-22
- Last updated
- 2021-09-30
Locations
3 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT04720599. Inclusion in this directory is not an endorsement.