Evaluation of SureCore Plus Biopsy System

NCT06550960 | Not Yet Recruiting

• 1 other identifier: 23-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

BPH

Outcome Measures

Primary Outcomes (2)

• Procedure success

  \> 3 mm/cc of tissue collected in each biopsy

  During the procedure

• Quality of biopsy tissue

  Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.

  During the procedure

Secondary Outcomes (1)

• Performance of the study device

  During the procedure

Study Arms (2)

SureCore Plus biopsy needle

EXPERIMENTAL

Prostate biopsy of subject with BPH with a SureCore biopsy needle

Device: Evaluation of two biopsy systems

Standard of Care biopsy needle

ACTIVE COMPARATOR

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

Device: Evaluation of two biopsy systems

Interventions

Evaluation of two biopsy systems 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; SureCore Plus biopsy needle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: This is biopsy of the prostate. Only males have a prostate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uro-1 Medical: lead

Study Officials

• Jeffrey Proctor, MD

  Georgia Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Proctor, MD

CONTACT

770 607 1893; jproctor@georgiaurology.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm study of study biopsy needle and standard of care biopsy needle

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 13, 2024
• Study Start: August 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share