Clinical Trial

Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

Recruiting
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Summary
This randomized non-inferiority study evaluates whether a robot-assisted radical prostatectomy (RARP) training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model is as effective as the current standard training pathway in achieving surgical proficiency. Participants enrolled in a standardized robotic surgery training course will be randomly assigned to one of two training pathways that differ only in the training model used during one phase of the course. All participants will subsequently undergo assessment during human cadaver training. The primary outcome is the proportion of participants who achieve predefined proficiency criteria during the final assessment. Secondary outcomes include technical performance scores, technical errors, self-reported confidence, perceived readiness to perform robot-assisted radical prostatectomy, and feasibility of implementing a synthetic model-based training pathway. The study aims to determine whether a high-fidelity hydrogel model can provide training outcomes comparable to those achieved with biological models, supporting more ethical, scalable, and standardized robotic surgery training.
Trial Details
NCT Number NCT07669974
Lead Sponsor Orsi Academy
Conditions Robot-Assisted Radical Prostatectomy Training, Prostatectomy
Enrollment 56 participants
Start Date 2026-06-15
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-25