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Completed

NCT Number: NCT07174479

Eye Gaze Guidance Evaluation in Phantoms

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Urology residents at Vanderbilt University Medical Center

Exclusion criteria

-

Treatment and study plan

Augmented reality

Device

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

Primary outcomes

  1. Completeness of Kidney Exploration

    Time frame: up to 24 hours after the study was completed by the participant

    Percentage of kidney that was visualized

Secondary outcomes

  1. Gaze Path of the User While Performing Kidney Exploration

    Time frame: up to 24 hours after experiment completed by the participant

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

  2. Completion Time

    Time frame: up to 24 hours after experiment completed by the participant

    Time for the stone identification task

  3. Stone Count

    Time frame: up to 24 hours after experiment completed by the participant

    Number of stones seen

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • Vanderbilt University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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