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NOT YET RECRUITING
NCT06830265
NA

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

Sponsor: Uro-1 Medical

View on ClinicalTrials.gov

Summary

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.

Official title: Comparing a Standard of Care Prostate Biopsy System with a Novel System Using Standard As Well As Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-02-15

Completion Date

2026-01-10

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

DEVICE

Novel needle biopsy catheter (test)

Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample