Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate

Uro-1 Medical

Status: Not yet enrolling

Conditions: Prostate Disease

Treatments: Device: Prostate biopsy needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05470127

SUREcore v. SOC

Details and patient eligibility

About

Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.

Full description

The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male scheduled for prostate biopsy
• Able to provide informed consent
• Able and willing to provide verbal assessment of his condition 5 days post-procedure

Exclusion criteria

• Unwilling to provide consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

SUREcore biopsy needle

Experimental group

Description:

The SUREcore needle will be used to collect up to 10 tissue samples

Treatment:

Device: Prostate biopsy needle

Standard of Care biopsy needle

Active Comparator group

Description:

The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples

Treatment:

Device: Prostate biopsy needle