UrologyNCT07566078
Artificial Intelligence (AI)-Based Intraoperative Visualization is Increasingly Integrated Into Robotic Surgery Platforms; However, Its Impact on Surgeons' Cognitive Workload Remains Unclear. This Study Evaluated Perceived Workload Among Console Surgeons and Bedside Assistants According to Different
A study testing Yolo in people with Urology, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Robotic surgery is now widely adopted in urology, and the da Vinci Single-Port (SP) platform enables complex procedures through a single multichannel incision, with favorable perioperative and outpatient outcomes in selected patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urology
- What is being tested?
- Yolo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: not urology surgeon or not urology resident
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of AI Visualization on Surgeons' Cognitive Workload in Single-Port Robotic Surgery
Robotic surgery is now widely adopted in urology, and the da Vinci Single-Port (SP) platform enables complex procedures through a single multichannel incision, with favorable perioperative and outpatient outcomes in selected patients. However, single-port access and AI implementation also introduce unique ergonomic and cognitive challenges for surgeons and operating room staff. Quantifying intraoperative workload has become crucial to understand how new technologies affect performance, safety and training.
The National Aeronautics and Space Administration Task Load Index (NASA-TLX) is a validated multidimensional instrument for subjective workload assessment and has been increasingly applied to surgical and specifically urologic practice. In parallel, augmented reality and artificial intelligence (AI) are emerging as tools to enhance intraoperative visualization and anatomical understanding during robot-assisted urologic procedures. The da Vinci TilePro multi-image display already allows simultaneous viewing of auxiliary imaging, but evidence on how real-time AI overlays integrated via TilePro affect cognitive workload in single-port urologic surgery is lacking. This prospective pilot study evaluates the impact of different TilePro visualization strategies on surgeon and bedside assistant workload, measured by weighted NASA-TLX scores, and explores associations with operative metrics in elective SP urologic procedures.
- Conditions
- Urology
- Being tested
- Yolo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YoloOther
The AI system employed in this study was based on a convolutional neural network (CNN) architecture implemented via the YOLO (You Only Look Once) framework, specifically designed for real-time instance segmentation of intraoperative anatomical structures.
| Study group | Role | What they receive |
|---|---|---|
| Continuous AI visualization | Active comparator | the AI overlay was displayed continuously throughout the entire surgical procedure. Receives: Other: Yolo |
| Intermittent AI visualization | Active comparator | The operator selectively activated the AI visualization during key surgical phases according to preference Receives: Other: Yolo |
| No AI visualization | No intervention | No AI visualization use |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASA Task Load Index (NASA-TLX) questionnaire
The National Aeronautics and Space Administration Task Load Index (NASA-TLX) is a validated multidimensional instrument for subjective workload assessment and has been increasingly applied to surgical and specifically urologic practice
Measured: 30 minutes after completing the surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrologyStudies 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
- Model description
- The urology single port surgeries are categorized into three AI visualization modes according to the use of the TilePro display: Continuous AI visualization (n = 10): the AI overlay was displayed continuously throughout the entire surgical procedure. Intermittent AI visualization (n = 10): the first operator selectively activated the AI visualization during key surgical phases according to preference. Control cases with no AI (n = 10): TilePro off and a full-screen image of the operative field.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Crivellaro, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566078
- Sponsor's protocol ID
- 2026-0199
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The NASA Task Load Index (NASA-TLX) questionnaire administered within 30 minutes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of AI Visualization on Surgeons' Cognitive Workload in Single-Port Robotic Surgery
- ClinicalTrials.gov ID
- NCT07566078
- Acronym / sponsor ID
- 2026-0199
- Conditions
- Urology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 May 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.
Robotic surgery is now widely adopted in urology, and the da Vinci Single-Port (SP) platform enables complex procedures through a single multichannel incision, with favorable perioperative and outpatient outcomes in selected patients. However, single-port access and AI implementation also introduce unique ergonomic and cognitive challenges for surgeons and operating room staff. Quantifying intraoperative workload has become crucial to understand how new technologies affect performance, safety and training.
The National Aeronautics and Space Administration Task Load Index (NASA-TLX) is a validated multidimensional instrument for subjective workload assessment and has been increasingly applied to surgical and specifically urologic practice. In parallel, augmented reality and artificial intelligence (AI) are emerging as tools to enhance intraoperative visualization and anatomical understanding during robot-assisted urologic procedures. The da Vinci TilePro multi-image display already allows simultaneous viewing of auxiliary imaging, but evidence on how real-time AI overlays integrated via TilePro affect cognitive workload in single-port urologic surgery is lacking. This prospective pilot study evaluates the impact of different TilePro visualization strategies on surgeon and bedside assistant workload, measured by weighted NASA-TLX scores, and explores associations with operative metrics in elective SP urologic procedures.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The urology single port surgeries are categorized into three AI visualization modes according to the use of the TilePro display: Continuous AI visualization (n = 10): the AI overlay was displayed continuously throughout the entire surgical procedure. Intermittent AI visualization (n = 10): the first operator selectively activated the AI visualization during key surgical phases according to preference. Control cases with no AI (n = 10): TilePro off and a full-screen image of the operative field.
| Arm | Type | Receives |
|---|---|---|
| Continuous AI visualization | Active comparator | Other: Yolothe AI overlay was displayed continuously throughout the entire surgical procedure. |
| Intermittent AI visualization | Active comparator | Other: YoloThe operator selectively activated the AI visualization during key surgical phases according to preference |
| No AI visualization | No intervention | –No AI visualization use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: not urology surgeon or not urology resident
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| YoloThe AI system employed in this study was based on a convolutional neural network (CNN) architecture implemented via the YOLO (You Only Look Once) framework, specifically designed for real-time instance segmentation of intraoperative anatomical structures. | Other | Continuous AI visualization, Intermittent AI visualization |
Primary outcome
NASA Task Load Index (NASA-TLX) questionnaire
Time frame: 30 minutes after completing the surgey
The National Aeronautics and Space Administration Task Load Index (NASA-TLX) is a validated multidimensional instrument for subjective workload assessment and has been increasingly applied to surgical and specifically urologic practice
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 4 May 2026.
- Individual participant dataSharing planned: Yes. The NASA Task Load Index (NASA-TLX) questionnaire administered within 30 minutes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yolo in people with Urology, run by University of Illinois at Chicago at 1 site in United States.
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 0 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: under way, not looking for participants, as of the sponsor's last update on 4 May 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 United States. 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?
NASA Task Load Index (NASA-TLX) questionnaire (time frame: 30 minutes after completing the surgey). 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 4 May 2026.