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Evaluation of Eye Gaze Sharing in the Operating Room

StatusCompleted
PhaseNot applicable
Started2025-01-31
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
notable
Trial completed
2026-05-19
minor
Study Status, Study Description, Study Design, Eligibility v2
Primary completion date2026-08→2026-08-03
Completion date2026-08→2026-08-31
Enrollment target15→110
Eligibility criteria+327 characters
Inclusion Criteria: UrologySurgeons who are "adult" residents and attending urologists at Vanderbilt University Medical Center in the age range 18 to 65 Patients who are adults with kidney stones scheduled for endoscopic surgery as clinically indicated. Exclusion Criteria: -Vulnerable populations, including incarceration status, pregnancy, inability to give informed consent, and serious illness likely to cause death within 5 years
Study description+4,272 characters
SpecificallyWe will perform a clinical trial to quantitatively evaluate the benefits of gaze sharing for stone localization in patients. The trainees and experts surgeons will be prospectively randomized into the control and experimental groups. Specifically, each trainee (N=10) will be tasked with stone localization as is standard of care during ten endoscopic stone surgery under the guidance of an ex [...] this studyclinical trial, the investigators are asking surgical trainees and experts [...] in the operating room while conducting kidney stone surgery on consenting patients (~N of 100) enrolled for th [...] [...]
2025-11-18
minor
Study Status, Document Section v1
Re-verified, no change to tracked fields
2025-09-08
minor
Original filing
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.
Trial Details
NCT Number NCT07173309
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB), Vanderbilt University
Conditions Kidney Stones
Enrollment 100 participants
Start Date 2025-01-31
Primary Completion 2026-08-23 (estimated)
Study Completion 2026-08-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-24