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RECRUITING
NCT07669974
NA

Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

Sponsor: Orsi Academy

View on ClinicalTrials.gov

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.

Official title: A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-06-15

Completion Date

2027-06-15

Last Updated

2026-06-25

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

IMRA-Enhanced Training Pathway

Structured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.

BEHAVIORAL

Standard Training Pathway

Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model

Locations (1)

Orsi Academy

Melle, Belgium, Belgium