Evaluation of SureCore Plus Biopsy System

NCT ID: NCT06550960

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-02-01

Brief 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.

Detailed Description

Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.

Conditions

BPH

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SureCore Plus biopsy needle

Prostate biopsy of subject with BPH with a SureCore biopsy needle

Group Type: EXPERIMENTAL

Evaluation of two biopsy systems

Intervention Type: DEVICE

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

Standard of Care biopsy needle

Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle

Group Type: ACTIVE_COMPARATOR

Evaluation of two biopsy systems

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient has BPH requiring a prostate biopsy
• Able and willing to provide consent

Exclusion Criteria

• Active infection
• Subject participating in an other device study of the prostate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Uro-1 Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Proctor, MD

Role: PRINCIPAL_INVESTIGATOR

Georgia Urology

Central Contacts

Jeffrey Proctor, MD

Role: CONTACT

jproctor@georgiaurology.com

770 607 1893

Other Identifiers

23-01

Identifier Type: -

Identifier Source: org_study_id