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Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

NCT07271017 · Johns Hopkins University · Updated 8 Dec 2025

What is being tested
Prostate biopsy
For
Prostate Cancer (Diagnosis)
Kind of study
Tests a treatment or device on volunteers. Phase 1.
Who can join
Ages 40 years to 75 years. About 60 people. The full rules are on the registry page.
Where
United States
When
Starts or started 23 Sept 2025, ends 31 May 2030. Registered 8 Dec 2025.
Results
None posted yet.

In the researchers' words

Prostate cancer (PCa) is the most diagnosed type of cancer and the second leading cause of cancer related deaths among US men, and its incidence has increased steadily in the last decade. Efforts to address the rise in PCa diagnosis without overdetection and overtreatment include targeted biopsy techniques for clinically significant PCa using magnetic resonance imaging (MRI), and precision targeted biopsy guided by ultrasound and fused to the MRI. The study aims to improve prostate biopsy with a novel ultrasound probe and robot developed at Johns Hopkins, the ProBot device. The trial is a Phase 1 clinical trial to evaluate the safety and feasibility of the new device. ProBot is an entirely new concept including a novel ultrasound probe and robot kinematics specifically designed for the prostate. It operates with only two degrees of freedom configured such that the motions for 3D image scanning and biopsy may not deform the prostate gland, thus improving the accuracy of MRI-ultrasound fusion and needle targeting at biopsy. ProBot is a small and lightweight robot (1.3Kg including the ultrasound probe). It allows hands-free operation of its ultrasound probe at 3D image scanning and needle targeting supervised by the urologist. In addition to MRI-targeted biopsy (TB), at systematic biopsy (SB), instead of using the common template plan that is the same for all patients, the…
ClinicalTrials.gov, NCT07271017

Sites

  • Johns Hopkins HospitalBaltimore, Maryland, United States