Evaluation of Eye Gaze Sharing in the Operating Room

NCT ID: NCT07173309

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-08-31

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 operating room while conducting kidney stone surgery. 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. The intervention is only during the kidney exploration phase of the surgery. The augmented reality is turned off during the rest of the surgery, which proceeds per standard of care.

Conditions

Kidney Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AR guided

Trainees can see experts' gaze through the HoloLens

Group Type: EXPERIMENTAL

Augmented reality

Intervention Type: DEVICE

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

Non-AR guided

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Augmented reality

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Urology residents at Vanderbilt University Medical Center

Exclusion Criteria

-

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Kavoussi

Assistant Professor Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicholas L Kavoussi, MD

Role: CONTACT

nicholas.l.kavoussi@vumc.org

615-343-1317

Jie Ying Wu, PhD

Role: CONTACT

jieying.wu@vanderbilt.edu

615-343-4996

Facility Contacts

Nicholas L Kavoussi, MD

Role: primary

nicholas.l.kavoussi@vumc.org

615-343-1317

Jie Ying Wu, PhD

Role: backup

jieying.wu@vanderbilt.edu

401-241-8160

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21EB035783-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

231997B

Identifier Type: -

Identifier Source: org_study_id