Evaluation of SureCore Plus Biopsy System

Uro-1 Medical

Status: Not yet enrolling

Conditions: BPH

Treatments: Device: Evaluation of two biopsy systems

Study type: Interventional

Funder types: Industry

Identifiers

NCT06550960

23-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SureCore Plus biopsy needle

Experimental group

Description:

Prostate biopsy of subject with BPH with a SureCore biopsy needle

Treatment:

Device: Evaluation of two biopsy systems

Standard of Care biopsy needle

Active Comparator group

Description:

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

Treatment:

Device: Evaluation of two biopsy systems