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

Primary Purpose

Prostate Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prostate biopsy needle
Sponsored by
Uro-1 Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SUREcore biopsy needle

    Standard of Care biopsy needle

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Procedure Success
    Percentage of tissue samples collected that are suitable for pathological review
    Core length of tissue in the sample
    Quantity of Tissue Samples Collected
    weight of tissue in the sample
    Quantity of Tissue Samples Collected
    Tissue Sample Preparation
    Time required to prepare the tissue samples for pathological review

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 11, 2022
    Last Updated
    July 21, 2022
    Sponsor
    Uro-1 Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05470127
    Brief Title
    Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate
    Official Title
    Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uro-1 Medical

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The two biopsy needle sets will be used in the same patient during the procedure.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SUREcore biopsy needle
    Arm Type
    Experimental
    Arm Description
    The SUREcore needle will be used to collect up to 10 tissue samples
    Arm Title
    Standard of Care biopsy needle
    Arm Type
    Active Comparator
    Arm Description
    The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples
    Intervention Type
    Device
    Intervention Name(s)
    Prostate biopsy needle
    Intervention Description
    Prostate tissue biopsy with a biopsy needle
    Primary Outcome Measure Information:
    Title
    Procedure Success
    Description
    Percentage of tissue samples collected that are suitable for pathological review
    Time Frame
    1 Day of the procedure
    Title
    Core length of tissue in the sample
    Description
    Quantity of Tissue Samples Collected
    Time Frame
    1 Day of the procedure
    Title
    weight of tissue in the sample
    Description
    Quantity of Tissue Samples Collected
    Time Frame
    1 Day of the procedure
    Title
    Tissue Sample Preparation
    Description
    Time required to prepare the tissue samples for pathological review
    Time Frame
    1 Day of the procedure
    Secondary Outcome Measure Information:
    Title
    Ease of use of the biopsy needle
    Description
    Utility of the biopsy needle measured with a Likert scale of 1 to 5
    Time Frame
    1 Day of the procedure

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Prostate tissue is to be collected, which is only present in males.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Lawson, PhD
    Phone
    5102061794
    Email
    drthomlawson@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jack Snoke
    Phone
    3365750434
    Email
    pjsnoke@uro1medical.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Lawson, PhD
    Organizational Affiliation
    Lawson & Associates
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Likert scale means for use of either of the biopsy needles will be available upon request

    Learn more about this trial

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

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