Evaluation of SureCore Plus Biopsy System

August 8, 2024 updated by: Uro-1 Medical

Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SureCore Plus biopsy needle
Prostate biopsy of subject with BPH with a SureCore biopsy needle
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
Active Comparator: Standard of Care biopsy needle
Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure success
Time Frame: During the procedure
> 3 mm/cc of tissue collected in each biopsy
During the procedure
Quality of biopsy tissue
Time Frame: During the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the study device
Time Frame: During the procedure
Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uro-1 Medical

Investigators

  • Principal Investigator: Jeffrey Proctor, MD, Georgia Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 5, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 23-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on BPH

Clinical Trials on Evaluation of two biopsy systems

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe