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Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

NCT07669974 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • Robot-Assisted Radical Prostatectomy Training
  • Prostatectomy

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

Sponsors & Collaborators

  • Orsi Academy

    lead OTHER

Principal Investigators

  • Niki Rashidian · Orsi Academy

  • Alexandre Mottrie · Orsi Academy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-06-15
Completion
2027-06-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669974 on ClinicalTrials.gov