RecruitingNot ApplicableNCT06830265

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

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.


Sponsor

Uro-1 Medical

Enrollment

200 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Novel needle biopsy catheter (test) for people with prostate cancer screening. The study is currently recruiting participants at 3 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICENovel needle biopsy catheter (test)

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


Locations(3)

NYU Langone

New York, New York, United States

Duke University

Durham, North Carolina, United States

Novant Health Coastal Carolina Medical Center

Hardeeville, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06830265


Related Trials