NCT05470127

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Uro-1 Medical · Industry
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Disease
• Prostate CA

Interventions

Type	Name	Description
DEVICE	Prostate biopsy needle	Prostate tissue biopsy with a biopsy needle

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2022-07-22
• Last updated: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study