Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

Part of paid clinical trials in Cartersville, Georgia.

Sponsor
Uro-1 Medical
Study ID
NCT05470127
Status
Recruiting
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Conditions

  • Prostate CA
  • Prostate Disease

Eligibility Criteria

Sex
MALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Prostate biopsy needle — DEVICE
    Prostate tissue biopsy with a biopsy needle

Study Details

Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.

Key Dates

Start date
Aug 1, 2022
Status verified
May 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: SUREcore biopsy needle
    The SUREcore needle will be used to collect up to 10 tissue samples
  • Active Comparator: Standard of Care biopsy needle
    The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples

Primary Outcome Measure

Procedure Success [ Time Frame: 1 Day of the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia UrologyCartersvilleGeorgia30115
Jeffrey Proctor, MD
[email protected]
7706071893
Jeffrey Proctor, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Georgia Urology· Cartersville, GA

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