Robotic Cardiac Surgery SimulationNCT05043064
Robotic Cardiac Surgery Wet Lab Simulation Study
A study testing Wet lab tasks in people with Robotic Cardiac Surgery Simulation, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Robotic Cardiac Surgery Simulation
- What is being tested?
- Wet lab tasks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Experienced robotic cardiac surgeons: robotic surgeons with total volume > 50 robotic cardiac operations and at least 20 robotic cases annually
- Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
- Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)
Who cannot join
- Robotic novices with > 5 hours experience of any robotic system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs
The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.
- Conditions
- Robotic Cardiac Surgery Simulation
- Being tested
- Wet lab tasks
- Keywords
- Robotic Cardiac Surgery, Wet Lab Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet lab tasksProcedure or surgery
Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
| Study group | Role | What they receive |
|---|---|---|
| Experienced robotic cardiac surgeons | Active comparator | Not described Receives: Procedure: Wet lab tasks |
| Cardiac surgeons with limited robotic experience | Active comparator | Not described Receives: Procedure: Wet lab tasks |
| Non-cardiac surgeons with limited robotic experience | Active comparator | Not described Receives: Procedure: Wet lab tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-based Score
The time-based score (TBS) was calculated as follows:
TBS = maximal total training time per task - actual completion time - errors.
Units of measure - seconds. Minimum score 0, Maximum score 1222.
TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task.
The score range
Measured: 6 months
Secondary outcomes (1)
Modified Global Evaluative Assessment of Robotic Skills (mGEARS)
In modified Global Evaluative Assessment of Robotic Skills (mGEARS) the tasks were not rated on autonomy domain as autonomy could not be evaluated from recordings.
The mGEARS score was used to evaluate the overall robotic proficiency by 5 domains: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. The score ranged from 5 to 25, where 5 and 25 indicated the least and most proficient performance, respectively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Robotic Cardiac Surgery SimulationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennady Atroshchenko, Aalborg University Hospital
- Investigators
- Gennady V Atroshchenko, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043064
- Sponsor's protocol ID
- 2020-000992-55
- Status last verified
- Feb 2025
- First submitted
- 1 Sep 2021
- Last updated
- 26 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atroshchenko GV, Korup LR, Hashemi N, Ostergaard LR, Tolsgaard MG, Rasmussen S. Artificial intelligence-based action recognition and skill assessment in robotic cardiac surgery simulation: a feasibility study. J Robot Surg. 2025 Jul 13;19(1):384. doi: 10.1007/s11701-025-02563-3.
PubMed 40652436Atroshchenko GV, Navarra E, Valdis M, Sandoval E, Hashemi N, Cerny S, Pereda D, Palmen M, Bjerrum F, Bruun NH, Tolsgaard MG. Simulation-based assessment of robotic cardiac surgery skills: An international multicenter, cross-specialty trial. JTCVS Open. 2023 Nov 2;16:619-627. doi: 10.1016/j.xjon.2023.10.029. eCollection 2023 Dec.
PubMed 38204726
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs
- ClinicalTrials.gov ID
- NCT05043064
- Acronym / sponsor ID
- 2020-000992-55
- Conditions
- Robotic Cardiac Surgery Simulation
- Keywords
- Robotic Cardiac Surgery, Wet Lab Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Posted 26 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experienced robotic cardiac surgeons | Active comparator | Procedure: Wet lab tasks |
| Cardiac surgeons with limited robotic experience | Active comparator | Procedure: Wet lab tasks |
| Non-cardiac surgeons with limited robotic experience | Active comparator | Procedure: Wet lab tasks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Experienced robotic cardiac surgeons: robotic surgeons with total volume > 50 robotic cardiac operations and at least 20 robotic cases annually
- Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
- Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)
Key exclusion criteria (1 listed)
- Robotic novices with > 5 hours experience of any robotic system
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 |
|---|---|---|
| Wet lab tasksRobotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model | Procedure or surgery | Cardiac surgeons with limited robotic experience, Experienced robotic cardiac surgeons, Non-cardiac surgeons with limited robotic experience |
Primary outcome
Time-based Score
Time frame: 6 months
The time-based score (TBS) was calculated as follows: TBS = maximal total training time per task - actual completion time - errors. Units of measure - seconds. Minimum score 0, Maximum score 1222. TBS was calculated in seconds, where 0 was the lowest score and a higher number indicated a faster time to perform the task. The score range
1 secondary outcome
Modified Global Evaluative Assessment of Robotic Skills (mGEARS)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40652436Atroshchenko GV, Korup LR, Hashemi N, Ostergaard LR, Tolsgaard MG, Rasmussen S. Artificial intelligence-based action recognition and skill assessment in robotic cardiac surgery simulation: a feasibility study. J Robot Surg. 2025 Jul 13;19(1):384. doi: 10.1007/s11701-025-02563-3.
- Derived from this study: PubMed 38204726Atroshchenko GV, Navarra E, Valdis M, Sandoval E, Hashemi N, Cerny S, Pereda D, Palmen M, Bjerrum F, Bruun NH, Tolsgaard MG. Simulation-based assessment of robotic cardiac surgery skills: An international multicenter, cross-specialty trial. JTCVS Open. 2023 Nov 2;16:619-627. doi: 10.1016/j.xjon.2023.10.029. eCollection 2023 Dec.
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. This study is not recruiting at the moment.
Gennady V Atroshchenko, MD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wet lab tasks in people with Robotic Cardiac Surgery Simulation, run by Aalborg University Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 26 Feb 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-based Score (time frame: 6 months). 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 NCT05043064, which also lists 2 linked publications.
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 26 Feb 2025.