Robot-Assisted Radical Prostatectomy TrainingNCT07669974
Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy
A study testing IMRA-Enhanced Training Pathway and Standard Training Pathway in people with Robot-Assisted Radical Prostatectomy Training and Prostatectomy, run by Orsi Academy at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Robot-Assisted Radical Prostatectomy Training, Prostatectomy
- What is being tested?
- IMRA-Enhanced Training Pathway and Standard Training Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Decline or inability to provide informed consent
- Incomplete participation in the on-site training course preventing assessment on Day 5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Orsi Academy
Melle, Belgium, 9090
Niki Rashidian, 09 334 69 26, niki.rashidian@orsi.be
About this study
Official title: A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy
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.
Read more
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.
Read the detailed description
Robot-assisted radical prostatectomy (RARP) is one of the most technically demanding procedures in robotic urologic surgery and requires structured training to ensure safe and effective skill acquisition. The Certified Curriculum in Robotic Radical Prostatectomy (CC-ERUS) is a proficiency-based training pathway developed by the European Association of Urology Robotic Urology Section (ERUS) to standardize training and assessment in RARP. The curriculum includes simulation-based training, biological models, and human cadaver training before participants are assessed for proficiency.
The use of biological training models presents ethical, logistical, regulatory, and scalability challenges. High-fidelity synthetic hydrogel models have recently been developed as potential alternatives that may provide realistic anatomical representation and tissue handling characteristics while reducing reliance on biological models. The present study evaluates whether incorporation of the IMRA Surgical Prostatectomy Class V Hydrogel Model within a standardized RARP training pathway results in training outcomes that are non-inferior to those achieved using the current standard training pathway.
This study is a prospective, randomized, controlled, non-inferiority trial embedded within a standardized five-day robotic surgery training course at ORSI Academy. Participants will be randomized in a 1:1 ratio to one of two training pathways. Both pathways are identical in educational content, duration, faculty supervision, and learning objectives. The only difference between groups is the training modality used during Day 4 of the course. Participants assigned to the standard pathway will train on human cadaver models, whereas participants assigned to the experimental pathway will train using the IMRA Surgical Prostatectomy Class V Hydrogel Model.
On Day 5, all participants will undergo training and assessment on human cadaver models under identical conditions. Technical performance will be evaluated using validated procedure-specific metrics for robot-assisted radical prostatectomy. The primary objective is to determine whether the hydrogel-based training pathway is non-inferior to the standard pathway with respect to achievement of predefined proficiency criteria during the final human cadaver assessment. Additional analyses will evaluate technical performance metrics, procedural errors, task completion parameters, participant confidence, perceived readiness to perform RARP, cognitive workload, and participant evaluation of the training pathway.
- Being tested
- IMRA-Enhanced Training Pathway, Standard Training Pathway
- Keywords
- Robot-Assisted Radical Prostatectomy, Robotic Surgery Training, Surgical Education, Proficiency-Based Progression Methodology, Hydrogel Model, Non-Inferiority Trial, Surgical Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRA-Enhanced Training PathwayBehavioural
Structured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.
Standard Training PathwayBehavioural
Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model
| Study group | Role | What they receive |
|---|---|---|
| IMRA-Enhanced Training Pathway | Experimental | Participants receive a robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model during day 4 of the training pathway. Receives: Behavioral: IMRA-Enhanced Training Pathway |
| Standard Training Pathway | Active comparator | Participants receive the standard robot-assisted radical prostatectomy training pathway (Human Cadaver on day 4) without the IMRA Surgical Prostatectomy Class V Hydrogel Model. Receives: Behavioral: Standard Training Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Proportion of participants achieving predefined proficiency criteria during the final human cadaver training assessment. Technical performance will be assessed using validated robot-assisted radical prostatectomy assessment metrics (Mottrie et al., doi:10.1111/bju.15311). Participants will be classified as proficient if they complete the assessed procedure with no more than 20 General Errors and 0 Critical Errors. The primary outcome will be the proportion of participants meeting these proficiency criteria.
Measured: At completion of Day 5 human cadaver training assessment
Secondary outcomes (4)
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Technical performance during the final human cadaver assessment will be evaluated using validated robot-assisted radical prostatectomy assessment metrics (Mottrie et al., doi:10.1111/bju.15311). The number of General Errors, the number of Critical Errors, and the time required to complete the procedure will be recorded and compared between study groups. Lower numbers of errors and shorter completion times indicate better technical performance.
Measured: At completion of Day 5 human cadaver training assessment
Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire
Participant confidence in performing robot-assisted radical prostatectomy will be assessed using the ORSI RARP Confidence Questionnaire, a study-specific Likert-scale questionnaire. Responses will be collected using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater confidence.
Measured: End of training course - Day 5
Workload Assessed Using the NASA Task Load Index (NASA-TLX)
Participant workload measured using the NASA Task Load Index questionnaire. Total score range: 0-100, with higher scores indicating greater perceived workload.
Measured: Immediately after completion of the relevant training session
Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire
Participant evaluation of the training pathway and educational experience will be assessed using the ORSI Training Pathway Evaluation Questionnaire, a study-specific post-course questionnaire. Responses will be collected using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability and satisfaction.
Measured: End of training course - Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robot-Assisted Radical Prostatectomy TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel training pathways. The intervention group receives training incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model, while the control group follows the standard training pathway. Both groups complete the same robotic surgery curriculum and undergo identical final assessment during human cadaver training. The primary comparison evaluates whether the IMRA-enhanced pathway is non-inferior to the standard pathway in achieving predefined proficiency criteria.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orsi Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niki Rashidian, Principal investigator, Orsi AcademyAlexandre Mottrie, Principal investigator, Orsi Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669974
- Sponsor's protocol ID
- ORSI-IMRA-2026-01
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mottrie A, Mazzone E, Wiklund P, Graefen M, Collins JW, De Groote R, Dell'Oglio P, Puliatti S, Gallagher AG. Objective assessment of intraoperative skills for robot-assisted radical prostatectomy (RARP): results from the ERUS Scientific and Educational Working Groups Metrics Initiative. BJU Int. 2021 Jul;128(1):103-111. doi: 10.1111/bju.15311. Epub 2020 Dec 20.
PubMed 33251703
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07669974
- Acronym / sponsor ID
- ORSI-IMRA-2026-01
- Keywords
- Robot-Assisted Radical Prostatectomy, Robotic Surgery Training, Surgical Education, Proficiency-Based Progression Methodology, Hydrogel Model, Non-Inferiority Trial, Surgical Simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Orsi AcademyUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Robot-assisted radical prostatectomy (RARP) is one of the most technically demanding procedures in robotic urologic surgery and requires structured training to ensure safe and effective skill acquisition. The Certified Curriculum in Robotic Radical Prostatectomy (CC-ERUS) is a proficiency-based training pathway developed by the European Association of Urology Robotic Urology Section (ERUS) to standardize training and assessment in RARP. The curriculum includes simulation-based training, biological models, and human cadaver training before participants are assessed for proficiency.
The use of biological training models presents ethical, logistical, regulatory, and scalability challenges. High-fidelity synthetic hydrogel models have recently been developed as potential alternatives that may provide realistic anatomical representation and tissue handling characteristics while reducing reliance on biological models. The present study evaluates whether incorporation of the IMRA Surgical Prostatectomy Class V Hydrogel Model within a standardized RARP training pathway results in training outcomes that are non-inferior to those achieved using the current standard training pathway.
This study is a prospective, randomized, controlled, non-inferiority trial embedded within a standardized five-day robotic surgery training course at ORSI Academy. Participants will be randomized in a 1:1 ratio to one of two training pathways. Both pathways are identical in educational content, duration, faculty supervision, and learning objectives. The only difference between groups is the training modality used during Day 4 of the course. Participants assigned to the standard pathway will train on human cadaver models, whereas participants assigned to the experimental pathway will train using the IMRA Surgical Prostatectomy Class V Hydrogel Model.
On Day 5, all participants will undergo training and assessment on human cadaver models under identical conditions. Technical performance will be evaluated using validated procedure-specific metrics for robot-assisted radical prostatectomy. The primary objective is to determine whether the hydrogel-based training pathway is non-inferior to the standard pathway with respect to achievement of predefined proficiency criteria during the final human cadaver assessment. Additional analyses will evaluate technical performance metrics, procedural errors, task completion parameters, participant confidence, perceived readiness to perform RARP, cognitive workload, and participant evaluation of the training pathway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel training pathways. The intervention group receives training incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model, while the control group follows the standard training pathway. Both groups complete the same robotic surgery curriculum and undergo identical final assessment during human cadaver training. The primary comparison evaluates whether the IMRA-enhanced pathway is non-inferior to the standard pathway in achieving predefined proficiency criteria.
| Arm | Type | Receives |
|---|---|---|
| IMRA-Enhanced Training Pathway | Experimental | Behavioral: IMRA-Enhanced Training PathwayParticipants receive a robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model during day 4 of the training pathway. |
| Standard Training Pathway | Active comparator | Behavioral: Standard Training PathwayParticipants receive the standard robot-assisted radical prostatectomy training pathway (Human Cadaver on day 4) without the IMRA Surgical Prostatectomy Class V Hydrogel Model. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Decline or inability to provide informed consent
- Incomplete participation in the on-site training course preventing assessment on Day 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRA-Enhanced Training PathwayStructured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway. | Behavioural | IMRA-Enhanced Training Pathway |
| Standard Training PathwayStandard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model | Behavioural | Standard Training Pathway |
Primary outcome
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Time frame: At completion of Day 5 human cadaver training assessment
Proportion of participants achieving predefined proficiency criteria during the final human cadaver training assessment. Technical performance will be assessed using validated robot-assisted radical prostatectomy assessment metrics (Mottrie et al., doi:10.1111/bju.15311). Participants will be classified as proficient if they complete the assessed procedure with no more than 20 General Errors and 0 Critical Errors. The primary outcome will be the proportion of participants meeting these proficiency criteria.
4 secondary outcomes
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Time frame: At completion of Day 5 human cadaver training assessment
Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire
Time frame: End of training course - Day 5
Workload Assessed Using the NASA Task Load Index (NASA-TLX)
Time frame: Immediately after completion of the relevant training session
Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire
Time frame: End of training course - Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 33251703Mottrie A, Mazzone E, Wiklund P, Graefen M, Collins JW, De Groote R, Dell'Oglio P, Puliatti S, Gallagher AG. Objective assessment of intraoperative skills for robot-assisted radical prostatectomy (RARP): results from the ERUS Scientific and Educational Working Groups Metrics Initiative. BJU Int. 2021 Jul;128(1):103-111. doi: 10.1111/bju.15311. Epub 2020 Dec 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niki Rashidian principal investigator
Orsi Academy
Alexandre Mottrie principal investigator
Orsi Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRA-Enhanced Training Pathway and Standard Training Pathway in people with Robot-Assisted Radical Prostatectomy Training and Prostatectomy, run by Orsi Academy at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Vanderstraeten (09 334 69 26, eva.vanderstraeten@orsi.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics (time frame: At completion of Day 5 human cadaver training assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.