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

NCT06830265

This study is recruiting at 2 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Prostate Cancer Screening

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 years and older
Sex
Male
Healthy volunteers
Not accepted
Sponsor
Uro-1 Medical
Last updated on ClinicalTrials.gov
September 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

North Carolina · 1

  • Duke University · Durham, NC

South Carolina · 1

  • Novant Health Coastal Carolina Medical Center · Hardeeville, SC

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.