Recruiting

AR Tool

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07173309

Conditions

Kidney Stones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Augmented reality

Study Details

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.

Conditions

Kidney Stones

Study ID

NCT07173309

Start date

Jan 31, 2025

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Surgeons 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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: AR guided

Trainees can see experts' gaze through the HoloLens

no intervention: Non-AR guided

Trainees cannot see experts' gaze through the HoloLens. This should be the standard of care control group.

Interventions

Augmented reality

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

Primary outcome measure

  • Completeness of kidney exploration [ Time Frame: 1-10 minutes ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Kidney Stones
  • Augmented Reality
  • Gaze Guidance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-22.