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Robot-Assisted MRI-Guided Prostate Biopsy

NCT02080052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-01-14

No results posted yet for this study

Summary

Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the procedure has high false-negative rates. This represents a daily problem for urologists managing the disease, creates uncertainty and emotional stress for patients, and initiates a cascade of repeat testing and biopsies which also burden the investigators healthcare system.

The investigators believe that prostate biopsy can be improved by using a new biopsy paradigm. The investigators plan to perform MRI-guided prostate biopsies with robot-assistance for orienting a needle-guide through which the biopsy is taken. The combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity compared to regular TRUS biopsies.

The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety. The needle-guide robot is an investigational device developed in their Urology Robotics Laboratory.

Conditions

Interventions

DEVICE

Robot-assisted prostate biopsy

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Mohamad E Allaf, MD · Johns Hopkins University

  • Mark W Ball, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-25
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080052 on ClinicalTrials.gov