Trial Outcomes & Findings for AR Projections for Eye-gaze Evaluation in Phantoms (NCT NCT07161024)

NCT ID: NCT07161024

Last Updated: 2026-04-20

Results Overview

percentages of stones seen; The NASA Task Load Index (NASA-TLX) assesses participants' subjective workload after completing all tasks under each control method. It includes six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated from 0 to 100, with higher scores indicating greater perceived workload. The overall task load index is calculated as the average of the six dimension scores, resulting in a total score ranging from 0 to 100, where higher scores represent greater overall task load.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

1-10 min

Results posted on

2026-04-20

Participant Flow

All urology residents at Vanderbilt University Medical Center were recruited between 10/14/2024 and 12/31/2024. We enrolled a total of 8 residents. They were contacted directly via email through the urology website.

No significant events occurred between enrollment and assignment of each group.

Participant milestones

Participant milestones
Measure
Enrolled Residents and Experts, Eye Gaze Metrics
This includes the eye gaze metrics for the enrolled residents as well as the expert surgeons.
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AR Projections for Eye-gaze Evaluation in Phantoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
Age, Continuous
32 years
n=129 Participants
Sex: Female, Male
Female
4 Participants
n=129 Participants
Sex: Female, Male
Male
4 Participants
n=129 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=129 Participants
Race (NIH/OMB)
Asian
3 Participants
n=129 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=129 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=129 Participants
Race (NIH/OMB)
White
2 Participants
n=129 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=129 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=129 Participants
Region of Enrollment
United States
8 Participants
n=129 Participants
eye gaze metrics, area of interest
1295 cm2
STANDARD_DEVIATION 448 • n=129 Participants

PRIMARY outcome

Timeframe: 1-10 min

Population: percentage of stones found.

percentages of stones seen; The NASA Task Load Index (NASA-TLX) assesses participants' subjective workload after completing all tasks under each control method. It includes six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated from 0 to 100, with higher scores indicating greater perceived workload. The overall task load index is calculated as the average of the six dimension scores, resulting in a total score ranging from 0 to 100, where higher scores represent greater overall task load.

Outcome measures

Outcome measures
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
Stone Count
no assistance
80 percentage
Standard Deviation 18
Stone Count
gaze assistance
92 percentage
Standard Deviation 10

SECONDARY outcome

Timeframe: 1-10 min

Population: total area of interest traveled by eye gaze on endoscopic monitor as measured by hololens

total area of eye gaze seen, Extracted from eye-camera recording from the HoloLens 2

Outcome measures

Outcome measures
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
Gaze Metrics
no assistance
1352 cm2
Standard Deviation 557
Gaze Metrics
gaze assistance
1091 cm2
Standard Deviation 505

SECONDARY outcome

Timeframe: 1-10 min

Time for the stone identification task

Outcome measures

Outcome measures
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
Completion Time
no assitance
225 seconds
Standard Deviation 130
Completion Time
gaze assistance
238 seconds
Standard Deviation 136

SECONDARY outcome

Timeframe: 1 min

Population: Hart and Staveland's NASA Task Load Index (TLX) method assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales.

Conducted after each trial for subjective feedback; Hart and Staveland's NASA Task Load Index (TLX) method assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales. total points 105. mean scores and standard deviation for each arm reported The NASA Task Load Index (NASA-TLX) assesses participants' subjective workload after completing all tasks under each control method. It includes six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated from 0 to 100, with higher scores indicating greater perceived workload. The overall task load index is calculated as the average of the six dimension scores, resulting in a total score ranging from 0 to 100, where higher scores represent greater overall task load.

Outcome measures

Outcome measures
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
NASA Task Load Index
no assistance
62 nasa task load index score
Standard Deviation 3
NASA Task Load Index
gaze assistance
49 nasa task load index score
Standard Deviation 3

POST_HOC outcome

Timeframe: 1-10 min

Population: urology trainees performed endoscopy in phantoms

Percentage of kidney that was visualized

Outcome measures

Outcome measures
Measure
AR Marker Test
n=8 Participants
Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect.
Kidney Exploration
70 percentage of collecting system visualiz
Standard Deviation 25 • Interval 69.0 to 70.0

Adverse Events

AR Marker Test

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicholas kavoussi

Vanderbilt University Medical Center

Phone: 4434651485

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place