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Robot-Assisted MRI-Guided Prostate Biopsy
NCT02080052 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated 14 Jan 2019
- What is being tested
- Robot-assisted prostate biopsy
- For
- Prostate Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 35 years to 75 years. About 5 people. The full rules are on the registry page.
- Where
- United States
- When
- Starts or started 25 July 2013, ends Jan 2016. Registered 6 March 2014.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- The Johns Hopkins HospitalBaltimore, Maryland, United States
