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Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis

StatusRecruiting
PhaseNot applicable
Started2025-07-07
View on ClinicalTrials.gov ↗
Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.

Amendment history 5 changes detected by DataLookout

2026-09-05
notable
Recruitment opened
2026-09-05
notable
Enrollment increased: 20 → 200 participants
2026-09-05
minor
Trial sites expanded: 0 → 3 locations
2026-09-05
critical
Primary completion pushed: 2025-11-30 → 2026-11-01
2026-09-05
minor
Completion pushed: 2026-01-10 → 2026-12-10
Trial Details
NCT Number NCT06830265
Lead Sponsor Uro-1 Medical
Collaborators: Duke University, NYU Langone Health, Novant Health, Inc.
Conditions Prostate Cancer Screening
Enrollment 200 participants
Start Date 2025-07-07
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-04