Eye Gaze Guidance Evaluation in Phantoms

Not Applicable

Recruiting

• Conditions: Kidney Stones

• Registration Number: NCT07174479
• Lead Sponsor: Vanderbilt University Medical Center

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. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.

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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-06
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2025-11-03
• Study Completion: 2025-11-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Urology residents at Vanderbilt University Medical Center

Exclusion Criteria

-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completeness of kidney exploration	1-10 minutes	Percentage of kidney that was visualized
Stone count	1-10 minutes	Number of stones seen

Secondary Outcome Measures

Name	Time	Method
Gaze path of the user while performing kidney exploration	1-10 minutes	Extracted from eye-camera recording from the HoloLens 2
Completion time	1-10 minutes	Time for the stone identification task
NASA Task Load Index	1 minute	Conducted after each trial for subjective feedback

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States