Robot-Assisted Prostate Biopsy with a Novel Ultrasound Probe (ProBot)

This study is testing a new device called ProBot, which uses a robot and a special ultrasound probe to perform prostate biopsies. The goal is to see if this new method is safe and works well for diagnosing prostate cancer. You might be able to join if you are a man between 40 and 75 years old and have certain "high risk" features, such as a high PSA (prostate-specific antigen) level or an abnormal digital rectal exam (DRE). Researchers will look at how much discomfort or pain you experience during the procedure and if there are any complications. This study is a Phase 1 trial, meaning it's an early step to check the device's safety and how practical it is to use.

Study design
This is an interventional study, which means participants will receive the ProBot prostate biopsy. It plans to enroll 60 men.
What's involved
You would undergo a prostate biopsy using the ProBot device. Complications will be recorded for up to one month after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Complications will be monitored for up to one month after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07271017

Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe

Recruiting
PHASE1Ages 40–75InterventionalDevice feasibility
Johns Hopkins University
~60 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Prostate biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device feasibility as assessed by patient discomfort score
Measured over Immediately after the procedure
+5 more outcomes measured
Prostate Cancer (Diagnosis)
1 sites across 1 states
Maryland1
  • Misop Han, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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  • Device feasibility as assessed by patient discomfort scoreImmediately after the procedure

    Scale 1-10, 10 highest discomfort

  • Device feasibility as assessed by maximal procedural painImmediately after the procedure

    Scale 1-10, 10 highest pain

  • Device feasibility as assessed by the rate of complicationsThroughout the study, each case recorded within 1 month of the procedure

    Rate of complications

  • Device feasibility as assessed by serious adverse eventsUp to 1 month post procedure

    Serious Adverse events throughout the study

  • Device feasibility as assessed by the rate of successful completion of casesImmediately post procedure

    Rate of cases completed successfully throughout the study

  • Device feasibility as assessed by the procedure timeImmediately post procedure

    Times of the procedures measured in minutes throughout the study