RECRUITING

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters

Quick Facts

Study Start:2022-08-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05470127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult male scheduled for prostate biopsy
  2. * Able to provide informed consent
  3. * Able and willing to provide verbal assessment of his condition 5 days post-procedure
  1. * Unwilling to provide consent

Contacts and Locations

Study Contact

Thomas Lawson, PhD
CONTACT
5102061794
drthomlawson@gmail.com
Jack Snoke
CONTACT
3365750434
pjsnoke@uro1medical.com

Principal Investigator

Thomas Lawson, PhD
STUDY_DIRECTOR
Lawson & Associates

Study Locations (Sites)

Georgia Urology
Cartersville, Georgia, 30115
United States

Collaborators and Investigators

Sponsor: Uro-1 Medical

  • Thomas Lawson, PhD, STUDY_DIRECTOR, Lawson & Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Prostate CA
  • Needle biopsy

Additional Relevant MeSH Terms

  • Prostate Disease
  • Prostate CA