Back to resultsAssessment of VMCore Biopsy Versus Standard of Care Biopsy
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VMCore Biopsy System
Standard of Care Biopsy Needle
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Male
- Scheduled for a prostate biopsy
- Able and willing to provide verbal assessment of his condition 5 days post-procedure
Exclusion Criteria:
- Unable or unwilling to provide consent
Sites / Locations
- Georgia UrologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VMCore Biopsy System
Standard of Care Biopsy Needle
Arm Description
The VMCore biopsy needle will 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 suitable for pathological review
Adverse Events
Incidence and Severity of Adverse events associated with use of the biopsy needles
Patient Pain During use of the biopsy needles
Pain measured with Likert Scale of 1 to 5
Secondary Outcome Measures
Mean Tissue volume for each sample taken
Length and diameter of tissue samples for cubic centimeters of volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04982536
Brief Title
Assessment of VMCore Biopsy Versus Standard of Care Biopsy
Official Title
A Proof of Concept Assessment of the VMCore Biopsy System for Sampling and Retrieving Prostate Biopsy Cores Compared to a Standard of Care Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (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
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
Detailed Description
This post-market study is being conducted in order to assess the capability of the VMCore biopsy needle to capture prostate tissue in subjects consenting to the use of both the VMCore needle and the urological practice's standard of care needle for twinned samples during a routine prostate biopsy procedure. The primary endpoints are to success in tissue core sampling, safety of the sampling, and subject's tolerance to the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each subject will have biopsy performed with both the study needle and a standard of care needle
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VMCore Biopsy System
Arm Type
Experimental
Arm Description
The VMCore biopsy needle will 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)
VMCore Biopsy System
Intervention Description
Prostate Examine
Intervention Type
Device
Intervention Name(s)
Standard of Care Biopsy Needle
Intervention Description
Prostate Examine
Primary Outcome Measure Information:
Title
Procedure Success
Description
Percentage of tissue samples suitable for pathological review
Time Frame
1 Day of the procedure
Title
Adverse Events
Description
Incidence and Severity of Adverse events associated with use of the biopsy needles
Time Frame
1 Day of the procedure
Title
Patient Pain During use of the biopsy needles
Description
Pain measured with Likert Scale of 1 to 5
Time Frame
1 Day of the procedure
Secondary Outcome Measure Information:
Title
Mean Tissue volume for each sample taken
Description
Length and diameter of tissue samples for cubic centimeters of volume
Time Frame
1 Day of the procedure
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males have a prostate
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male
Scheduled for a prostate biopsy
Able and willing to provide verbal assessment of his condition 5 days post-procedure
Exclusion Criteria:
Unable or 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
Organizational Affiliation
Uro-1 Medical
Official's Role
Study Director
Facility Information:
Facility Name
Georgia Urology
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Proctor, MD
Phone
770-607-1893
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No patient data will be shared among researchers. Tissue data may be shared
Learn more about this trial
Assessment of VMCore Biopsy Versus Standard of Care Biopsy
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