Status:

NOT_YET_RECRUITING

Evaluation of SureCore Plus Biopsy System

Lead Sponsor:

Uro-1 Medical

Conditions:

BPH

Eligibility:

MALE

18-80 years

Phase:

NA

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 vo...

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 adeq...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

August 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06550960

Start Date

August 5 2024

End Date

February 1 2025

Last Update

August 13 2024

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