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

Sponsor
Uro-1 Medical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05470127
Collaborator
(none)
50
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Prostate biopsy needle
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The two biopsy needle sets will be used in the same patient during the procedure.The two biopsy needle sets will be used in the same patient during the procedure.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SUREcore biopsy needle

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

Device: Prostate biopsy needle
Prostate tissue biopsy with a biopsy needle
Active Comparator: Standard of Care biopsy needle

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

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

Outcome Measures

Primary Outcome Measures

  1. Procedure Success [1 Day of the procedure]

    Percentage of tissue samples collected that are suitable for pathological review

  2. Core length of tissue in the sample [1 Day of the procedure]

    Quantity of Tissue Samples Collected

  3. weight of tissue in the sample [1 Day of the procedure]

    Quantity of Tissue Samples Collected

  4. Tissue Sample Preparation [1 Day of the procedure]

    Time required to prepare the tissue samples for pathological review

Secondary Outcome Measures

  1. Ease of use of the biopsy needle [1 Day of the procedure]

    Utility of the biopsy needle measured with a Likert scale of 1 to 5

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Uro-1 Medical

Investigators

  • Study Director: Thomas Lawson, PhD, Lawson & Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uro-1 Medical
ClinicalTrials.gov Identifier:
NCT05470127
Other Study ID Numbers:
  • SUREcore v. SOC
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Prostatic Diseases

Study Results

No Results Posted as of Jul 22, 2022