NCT07669974 Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy
| NCT ID | NCT07669974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Orsi Academy |
| Condition | Robot-Assisted Radical Prostatectomy Training |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2026-06-15 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Enrollment in the CC-ERUS training course or participants attending the same robotic RARP training course at ORSI Academy outside the formal CC-ERUS curriculum at ORSI Academy during the study period * Willingness and ability to provide informed consent for participation in the study Exclusion Criteria: * Decline or inability to provide informed consent * Incomplete participation in the on-site training course preventing assessment on Day 5
Contact & Investigator
Niki Rashidian
PRINCIPAL INVESTIGATOR
Orsi Academy
Frequently Asked Questions
Who can join the NCT07669974 clinical trial?
This trial is open to participants of all sexes, studying Robot-Assisted Radical Prostatectomy Training. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07669974 currently recruiting?
Yes, NCT07669974 is actively recruiting participants. Contact the research team at eva.vanderstraeten@orsi.be for enrollment information.
Where is the NCT07669974 trial being conducted?
This trial is being conducted at Melle, Belgium.
Who is sponsoring the NCT07669974 clinical trial?
NCT07669974 is sponsored by Orsi Academy. The principal investigator is Niki Rashidian at Orsi Academy. The trial plans to enroll 56 participants.