Evaluation of SureCore Plus Biopsy System

NCT06550960 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-13

No results posted yet for this study

Summary

This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.

Conditions

  • BPH

Interventions

DEVICE

Evaluation of two biopsy systems

Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate

Sponsors & Collaborators

  • Uro-1 Medical

    lead INDUSTRY

Principal Investigators

  • Jeffrey Proctor, MD · Georgia Urology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2024-12-31
Completion
2025-02-01

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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 NCT06550960 on ClinicalTrials.gov