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

NCT06830265 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Screening

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

Sponsors & Collaborators

Principal Investigators

  • Ted Belleza · Uro-1 Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-15
Primary Completion
2025-11-30
Completion
2026-01-10
FDA Device
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830265 on ClinicalTrials.gov