Eye Gaze Guidance Evaluation in Phantoms

NCT07174479 | Recruiting

• 2 other identifiers: 231997C1R21EB035783-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Kidney Stones; Augmented Reality; Gaze Guidance

Outcome Measures

Primary Outcomes (2)

• Completeness of kidney exploration

  Percentage of kidney that was visualized

  1 year

• Stone count

  Number of stones seen

  1 year

Secondary Outcomes (3)

• Gaze path of the user while performing kidney exploration

  1 year

• Completion time

  1 year

• NASA Task Load Index

  1 year

Study Arms (2)

AR guided

EXPERIMENTAL

Trainees can see experts' gaze through the HoloLens

Device: Augmented reality

Non-AR guided

NO INTERVENTION

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

Interventions

Augmented reality DEVICE

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

AR guided

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Urology residents at Vanderbilt University Medical Center

Sponsors & Collaborators

• Vanderbilt University: collaborator
• Vanderbilt University Medical Center: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicholas L Kavoussi, MD

CONTACT

615-343-1317; nicholas.l.kavoussi@vumc.org

Jie Ying Wu, PhD

CONTACT

615-343-4996; jieying.wu@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Urology

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): November 3, 2026
• Study Completion (Estimated): November 3, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: The data will be uploaded to the NIDDK repository by Aug 2026. We foresee the data being available indefinitely.
• Access Criteria: Access to individual data will be controlled through the NIDDK repository and available only for research purposes.

Locations

US (1)