- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07566078
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
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- UI Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Urology surgeon or urology resident -
Exclusion Criteria: not urology surgeon or not urology resident
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Continuous AI visualization
the AI overlay was displayed continuously throughout the entire surgical procedure.
|
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.
|
|
Active Comparator: Intermittent AI visualization
The operator selectively activated the AI visualization during key surgical phases according to preference
|
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.
|
|
No Intervention: No AI visualization
No AI visualization use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 minutes after completing the surgey
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-0199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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