Assessment of VMCore Biopsy Versus Standard of Care Biopsy

NCT04982536 | Unknown FDA Device

• 1 other identifier: VMCore Assessment
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Procedure Success

  Percentage of tissue samples suitable for pathological review

  1 Day of the procedure

• Adverse Events

  Incidence and Severity of Adverse events associated with use of the biopsy needles

  1 Day of the procedure

• Patient Pain During use of the biopsy needles

  Pain measured with Likert Scale of 1 to 5

  1 Day of the procedure

Secondary Outcomes (1)

• Mean Tissue volume for each sample taken

  1 Day of the procedure

Study Arms (2)

VMCore Biopsy System

EXPERIMENTAL

The VMCore biopsy needle will used to collect up to 10 tissue samples.

Device: VMCore Biopsy System

Standard of Care Biopsy Needle

ACTIVE COMPARATOR

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

Device: Standard of Care Biopsy Needle

Interventions

VMCore Biopsy System DEVICE

Prostate Examine

VMCore Biopsy System

Standard of Care Biopsy Needle DEVICE

Prostate Examine

Standard of Care Biopsy Needle

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only males have a prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Scheduled for a prostate biopsy
• Able and willing to provide verbal assessment of his condition 5 days post-procedure

You may not qualify if:

• Unable or unwilling to provide consent

Sponsors & Collaborators

• Uro-1 Medical: lead

Study Sites (1)

Georgia Urology

Cartersville, Georgia, 30120, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Lawson

  Uro-1 Medical

  STUDY DIRECTOR

Central Study Contacts

Thomas Lawson, PhD

CONTACT

5102061794; drthomlawson@gmail.com

Jack Snoke

CONTACT

3365750434; pjsnoke@uro1medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will have biopsy performed with both the study needle and a standard of care needle

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 29, 2021
• Study Start: July 19, 2020
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)