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

Prostate Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05470127
• Other study ID #: SUREcore v. SOC
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: Uro-1 Medical
• Contact: Thomas Lawson, PhD
• Phone: 5102061794
• Email: drthomlawson[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Disease
• Prostatic Diseases

Intervention

Device:
• Prostate biopsy needle
Prostate tissue biopsy with a biopsy needle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uro-1 Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Success	Percentage of tissue samples collected that are suitable for pathological review	1 Day of the procedure
Primary	Core length of tissue in the sample	Quantity of Tissue Samples Collected	1 Day of the procedure
Primary	weight of tissue in the sample	Quantity of Tissue Samples Collected	1 Day of the procedure
Primary	Tissue Sample Preparation	Time required to prepare the tissue samples for pathological review	1 Day of the procedure
Secondary	Ease of use of the biopsy needle	Utility of the biopsy needle measured with a Likert scale of 1 to 5	1 Day of the procedure