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.
COMPLETED
NA
8 participants
1-10 min
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
| Measure |
Enrolled Residents and Experts, Eye Gaze Metrics
This includes the eye gaze metrics for the enrolled residents as well as the expert surgeons.
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|---|---|
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Overall Study
STARTED
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8
|
|
Overall Study
COMPLETED
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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
| 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.
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|---|---|
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Age, Continuous
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32 years
n=129 Participants
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|
Sex: Female, Male
Female
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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
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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
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2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
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2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
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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 minPopulation: 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
| 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
|
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Stone Count
gaze assistance
|
92 percentage
Standard Deviation 10
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SECONDARY outcome
Timeframe: 1-10 minPopulation: 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
| 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 minTime for the stone identification task
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 minPopulation: 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
| 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
|
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NASA Task Load Index
gaze assistance
|
49 nasa task load index score
Standard Deviation 3
|
POST_HOC outcome
Timeframe: 1-10 minPopulation: urology trainees performed endoscopy in phantoms
Percentage of kidney that was visualized
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.
|
|---|---|
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Kidney Exploration
|
70 percentage of collecting system visualiz
Standard Deviation 25 • Interval 69.0 to 70.0
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Adverse Events
AR Marker Test
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place