NCT07566078

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Sep 2028

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes after completing the surgey

Study Arms (3)

Continuous AI visualization

ACTIVE COMPARATOR

the AI overlay was displayed continuously throughout the entire surgical procedure.

Other: Yolo

Intermittent AI visualization

ACTIVE COMPARATOR

The operator selectively activated the AI visualization during key surgical phases according to preference

Other: Yolo

No AI visualization

NO INTERVENTION

No AI visualization use

Interventions

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.

Continuous AI visualizationIntermittent AI visualization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UI Health

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Detection Algorithms

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 4, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The NASA Task Load Index (NASA-TLX) questionnaire administered within 30 minutes

Shared Documents
SAP

Locations