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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05470127
Other study ID # SUREcore v. SOC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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