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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT06830265

Public ClinicalTrials.gov record NCT06830265. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06830265
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Uro-1 Medical
Industry
Enrollment
200 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 6, 2025
Primary completion
Oct 31, 2026
Completion
Dec 9, 2026
Last update posted
Sep 3, 2026

2025 – 2026

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
NYU Langone New York New York 10016 Active, not recruiting
Duke University Durham North Carolina 27710 Recruiting
Novant Health Coastal Carolina Medical Center Hardeeville South Carolina 29927 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06830265, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06830265 live on ClinicalTrials.gov.

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