Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Public ClinicalTrials.gov record NCT07271017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 innovative software optimizes the plan for each patient to obtain a diagnosis that is representative of the whole gland histology. The ProBot robot is also uniquely capable of transrectal (TR) and transperineal (TP) biopsy. The aims of the study are to determine the safety and feasibility of the new device at TR and TP biopsies.
Study identification
- NCT ID
- NCT07271017
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 22, 2025
- Primary completion
- May 30, 2030
- Completion
- May 30, 2030
- Last update posted
- Dec 7, 2025
2025 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07271017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2025 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07271017 live on ClinicalTrials.gov.