Training EffectivenessNCT07180797
Proficiency-Based Progression on Hugo Ras Robot for Learning Nerve-Sparing RARP: Feasibility Study
An observational study of Training Effectiveness, run by Orsi Academy at 1 site in Belgium.
Trial summary
Feasibility study 1. To evaluate the feasibility of PBP training for nerve-sparing RARP on the Hugo Ras system 2. To assess time to proficiency for participants with varying experience 3. To identify challenges in PBP RARP training through observed errors and feedback Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Training Effectiveness
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2025to Mar 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: urology residents and urologists
Who may be able to join
- We'll only include urologist or urology residents to ensure that they have all the same interest and area of expertise
Who cannot join
- Prior experience with the Hugo robotic system. Participants unable to attend all training days. Non-urology residents or consultants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Feasibility study
- To evaluate the feasibility of PBP training for nerve-sparing RARP on the Hugo Ras system
- To assess time to proficiency for participants with varying experience
- To identify challenges in PBP RARP training through observed errors and feedback
Read the detailed description
As robotic surgery advances, the emergence of new platforms such as the Hugo™ Robotic-Assisted Surgery System calls for robust training frameworks. Proficiency-Based Progression (PBP) provides a structured method to ensure skill acquisition through clearly defined, measurable benchmarks. This study evaluates the feasibility of implementing a PBP curriculum to train urologists in nerve-sparing robot-assisted radical prostatectomy (RARP) using the Hugo™ system.
Twelve urologists and urology residents will participate, divided into three groups based on experience:
Robotic-naïve Intermediate (Da Vinci experience only) Expert RARP surgeons (Da Vinci experience without prior Hugo exposure)
The PBP training pathway comprises:
Cognitive modules (e-learning with MCQ validation) Psychomotor skills training (device familiarization and basic surgical skills) Procedural training (nerve-sparing RARP on porcine models)
Performance will be evaluated both in real time and via blinded video review.
Primary endpoints include the time to reach proficiency in basic skills and procedural steps, analyzed by prior experience. Secondary endpoints encompass error profiles, participant and instructor feedback, and the feasibility of standardizing proficiency metrics.
- Conditions
- Training Effectiveness
- Keywords
- surgery, training, robotic assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Robotic-naive participants | urology residents | |
| Group 2: Intermediate participants | Urologists or urology residents with generic robotic experience using the Intuitive platform, but no exposure to the Hugo system | |
| Group 3: Experienced participants | Experienced robotic consultants in RARP using the Intuitive platform, but no prior experience with the Hugo system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-to-proficiency for basic skills and procedural steps
- Time taken to achieve proficiency in basic robotic skills on the Hugo system.
- Time taken to achieve proficiency in RARP using the Hugo system in the simulated setting.
Measured: 9 months
Secondary outcomes (1)
Error patterns and feasibility of PBP RARP training on the Hugo system
Identification of challenging steps/phases in the PBP RARP procedure based on:
Number of errors committed Feedback from trainers Participant feedback on the training process (structured questionnaire)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start12 Sep 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training EffectivenessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orsi Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Van Herzeele, Professor, Principal investigator, Orsi Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180797
- Sponsor's protocol ID
- PBP feasibility - RARP - Hugo
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proficiency-Based Progression on Hugo Ras Robot for Learning Nerve-Sparing RARP: Feasibility Study
- ClinicalTrials.gov ID
- NCT07180797
- Acronym / sponsor ID
- PBP feasibility - RARP - Hugo
- Conditions
- Training Effectiveness
- Keywords
- surgery, training, robotic assisted surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Orsi AcademyUniversity, hospital or other
- Study start
- 12 Sep 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Sep 2025 (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.
Feasibility study
- To evaluate the feasibility of PBP training for nerve-sparing RARP on the Hugo Ras system
- To assess time to proficiency for participants with varying experience
- To identify challenges in PBP RARP training through observed errors and feedback
Detailed description
As robotic surgery advances, the emergence of new platforms such as the Hugo™ Robotic-Assisted Surgery System calls for robust training frameworks. Proficiency-Based Progression (PBP) provides a structured method to ensure skill acquisition through clearly defined, measurable benchmarks. This study evaluates the feasibility of implementing a PBP curriculum to train urologists in nerve-sparing robot-assisted radical prostatectomy (RARP) using the Hugo™ system.
Twelve urologists and urology residents will participate, divided into three groups based on experience:
Robotic-naïve Intermediate (Da Vinci experience only) Expert RARP surgeons (Da Vinci experience without prior Hugo exposure)
The PBP training pathway comprises:
Cognitive modules (e-learning with MCQ validation) Psychomotor skills training (device familiarization and basic surgical skills) Procedural training (nerve-sparing RARP on porcine models)
Performance will be evaluated both in real time and via blinded video review.
Primary endpoints include the time to reach proficiency in basic skills and procedural steps, analyzed by prior experience. Secondary endpoints encompass error profiles, participant and instructor feedback, and the feasibility of standardizing proficiency metrics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Robotic-naive participants | – | –urology residents |
| Group 2: Intermediate participants | – | –Urologists or urology residents with generic robotic experience using the Intuitive platform, but no exposure to the Hugo system |
| Group 3: Experienced participants | – | –Experienced robotic consultants in RARP using the Intuitive platform, but no prior experience with the Hugo system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- urology residents and urologists
Key inclusion criteria (1 listed)
- We'll only include urologist or urology residents to ensure that they have all the same interest and area of expertise
Key exclusion criteria (1 listed)
- Prior experience with the Hugo robotic system. Participants unable to attend all training days. Non-urology residents or consultants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time-to-proficiency for basic skills and procedural steps
Time frame: 9 months
* Time taken to achieve proficiency in basic robotic skills on the Hugo system. * Time taken to achieve proficiency in RARP using the Hugo system in the simulated setting.
1 secondary outcome
Error patterns and feasibility of PBP RARP training on the Hugo system
Time frame: 9 months
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 18 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Training Effectiveness
Enrolling by invitation
Clinician Motivational Interviewing Training Evaluation
Behavior Change Interventions, Evaluation
Recruiting
Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
Effectiveness, Biofeedback-Assisted Pelvic Floor Muscle Training
Not yet recruiting
Impact of Respiratory Training on Reaction Time and Other Performance Components in Young Football Players.
Training Effectiveness, Training Efficiency
Recruiting
Effectiveness of In-Situ Simulation Training in Adult Non-Trauma Resuscitation: A Comparison of ISS and OSS Team Performance Using the A-C-L-S Model
Adult Non-trauma Cardiac Arrest Resuscitation, Effectiveness of In-situ Simulation (ISS) Training
Recruiting
Effects of HIIT and Concurrent HITT/Plyometric Training on Muscle-tendon Structure, Function and Metabolism in Pediatric Population With Obesity at Different Biological Maturation States (HIIT-PRO Kids).
Pediatric Obesity, Training Effectiveness
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.
Isabelle Van Herzeele, Professor 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?
An observational study of Training Effectiveness, 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-to-proficiency for basic skills and procedural steps (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.