Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06550960

Evaluation of SureCore Plus Biopsy System

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

BPH

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Procedure success

    Time frame: During the procedure

    > 3 mm/cc of tissue collected in each biopsy

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Proctor, MD

CONTACT

[email protected]

770 607 1893

Sponsors and collaborators

Lead sponsor

Uro-1 Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.