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

Part of paid clinical trials in New York, New York.

Sponsor
Uro-1 Medical
Study ID
NCT06830265
Status
Recruiting
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Conditions

  • Prostate Cancer Screening

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novel needle biopsy catheter (test) — DEVICE
    Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample

Study Details

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.

Key Dates

First listed
Feb 17, 2025
Start date
Jul 7, 2025
Status verified
Sep 2026
Primary completion
Nov 1, 2026
Completion
Dec 10, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Test group
    The prostate of each subject will have a tissue removed by one needle in one lobe and the other needle in the other lobe.
  • Active Comparator: Single Arm
    The prostate will be biopsied in one lobe by the control needle biopsy system and the other lobe by the test needle biopsy system.

Primary Outcome Measure

Atypical Small Acinar Proliferation [ Time Frame: From enrollment to end of treatment at 1 day ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NYU LangoneNew YorkNew York10016-
Duke UniversityDurhamNorth Carolina27710
Jhoanna Z Aquino
[email protected]
919-660-6189
Brian Cuffe, BS
[email protected]
919-681-5557
Michael Rothberg, MD (PRINCIPAL_INVESTIGATOR)
Novant Health Coastal Carolina Medical CenterHardeevilleSouth Carolina29927
Kellie A King, RN
[email protected]
843-706-2255
Thomas Lawson, PhD
[email protected]
510-206-1794
Eric Gwynn, MD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone· New York, NYDuke University· Durham, NCNovant Health Coastal Carolina Medical Center· Hardeeville, SC

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