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Completed

NCT Number: NCT07161024

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

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Key information

Age range

13 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 each participant, all surgical trainees, to explore four phantom kidneys with stones added and count the number of stones. For each kidney phantom, the participants will have either one of three augmented reality markers to show where an expert is looking, or they will not have any visual guidance (standard of care). In all cases, the participants get verbal feedback from the expert surgeon. The goal is to compare the effect of the design of the AR marker on the trainee's performance in exploring the kidney phantom.

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 of different designs are tested to evaluate how they affect trainee performance.

Primary outcomes

  1. Stone Count

    Time frame: 1-10 min

    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.

Secondary outcomes

  1. Gaze Metrics

    Time frame: 1-10 min

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

  2. Completion Time

    Time frame: 1-10 min

    Time for the stone identification task

  3. NASA Task Load Index

    Time frame: 1 min

    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.

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
2024
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Apr 20, 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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