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NCT05470127 · ClinicalTrials.gov registry record · NA

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

A NA study of Prostate CA and Prostate Disease, sponsored by Uro-1 Medical.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT05470127 is a NA study of Prostate CA and Prostate Disease that is actively recruiting participants, run by Uro-1 Medical. The registered enrollment target is 200 participants, above the 91-participant average among 4 other Prostate CA trials with a reported enrollment target (120% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05470127, a NA study of Prostate CA and Prostate Disease, is actively recruiting participants, sponsored by Uro-1 Medical.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DEVICE Prostate biopsy needle

Study Locations (1)

Georgia

  • Georgia Urology - Cartersville

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2022-08-01
Est. Completion 2025-12
Phase NA

Sponsor

Uro-1 Medical

1 total trials

What the Registry Record Tells You About NCT05470127

The ClinicalTrials.gov registry entry for NCT05470127 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 91-participant average among 4 other Prostate CA trials with a reported enrollment target (120% higher). The listed sponsor is Uro-1 Medical, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prostate CA appearing as the primary indexed condition, and to 1 intervention - of which Prostate biopsy needle is the first listed.

NCT05470127 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT05470127 about?

NCT05470127 is a clinical study titled "Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters". 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 ...

What is the current status of trial NCT05470127?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2022-08-01. Estimated completion is 2025-12.

What conditions does trial NCT05470127 study?

This clinical trial studies the following conditions: Prostate CA, Prostate Disease.

What interventions are being tested in trial NCT05470127?

The interventions under investigation include: Prostate biopsy needle (DEVICE).

Who is sponsoring clinical trial NCT05470127?

This trial is sponsored by Uro-1 Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05470127 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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