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Eye Gaze Guidance Evaluation in Phantoms

Eye Gaze Guidance Evaluation in Phantoms

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07174479
Enrollment
10
Registered
2025-09-16
Start date
2025-02-21
Completion date
2025-11-03
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Keywords

Kidney Stones, Augmented Reality, Gaze Guidance

Brief summary

This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees.

Detailed description

Specifically for this study, the investigators are asking surgical trainees and experts to wear the HoloLens 2 in the a kidney stone identification phantom study. The investigators measure the eye gaze data of the trainee and expert using the HoloLens. In the experimental arm of the trial, the trainees get visual guidance through a hologram showing the expert's gaze in addition to the verbal guidance as their standard of care.

Interventions

DEVICEAugmented reality

Augmented reality markers show the surgical trainee the expert's gaze location during the kidney exploration phase of surgery.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Vanderbilt University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Urology residents at Vanderbilt University Medical Center

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Completeness of Kidney Explorationup to 24 hours after the study was completed by the participantPercentage of kidney that was visualized

Secondary

MeasureTime frameDescription
Gaze Path of the User While Performing Kidney Explorationup to 24 hours after experiment completed by the participantExtracted from eye-camera recording from the HoloLens 2, total gaze path seen
Completion Timeup to 24 hours after experiment completed by the participantTime for the stone identification task
Stone Countup to 24 hours after experiment completed by the participantNumber of stones seen

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous31 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Region of Enrollment
United States
5 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 5
other
Total, other adverse events
0 / 50 / 5
serious
Total, serious adverse events
0 / 50 / 5

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026