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.
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Misop Han, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- 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