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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EB035783-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR Marker Test | Experimental | Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented reality | Device | Augmented reality markers of different designs are tested to evaluate how they affect trainee performance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone Count | 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. | 1-10 min |
| Measure | Description | Time Frame |
|---|---|---|
| Gaze Metrics | total area of eye gaze seen, Extracted from eye-camera recording from the HoloLens 2 | 1-10 min |
| Completion Time | Time for the stone identification task |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
We will share the endoscope video and eye-gaze information from the study, and associated metadata, including the study protocol.
The manuscript describing the study method and findings has been accepted for publication and will appear in September. We plan to upload the data to the NIDDK repository by December 2025. We foresee both being available indefinitely.
Anyone can access the research manuscript with aggregate results. Access to individual data will be controlled through the NIDDK repository and available only for research purposes.
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No significant events occurred between enrollment and assignment of each group.
All urology residents at Vanderbilt University Medical Center were recruited between 10/14/2024 and 12/31/2024. We enrolled a total of 8 residents. They were contacted directly via email through the urology website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Residents and Experts, Eye Gaze Metrics | This includes the eye gaze metrics for the enrolled residents as well as the expert surgeons. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all participants we enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | AR Marker Test | Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age, continuous years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stone Count | 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. | percentage of stones found. | Posted | Mean | Standard Deviation | percentage | 1-10 min |
|
from enrollment until end of experiment, 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AR Marker Test | Each user performs a kidney stone identification task in phantoms with each of three augmented reality markers, and without any marker. The phantoms and markers ordering are randomized to reduce learning effect. |
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small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas kavoussi | Vanderbilt University Medical Center | 4434651485 | nicholas.l.kavoussi@vumc.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2024 | Feb 23, 2026 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2025 | Nov 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 1-10 min |
| NASA Task Load Index | 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. | 1 min |
| Full Range |
| years |
|
| Sex: Female, Male | gender, male or female | Count of Participants | Participants |
|
| Race (NIH/OMB) | race, demographic | Count of Participants | Participants |
|
| Region of Enrollment | region of enrollment, geographic | Number | Participants |
|
| eye gaze metrics, area of interest | evaluation of eye gaze metric (area of interest) during surgery | Median | Standard Deviation | cm2 |
|
|
|
| Post-Hoc | Kidney Exploration | Percentage of kidney that was visualized | urology trainees performed endoscopy in phantoms | Posted | Mean | Standard Deviation | percentage of collecting system visualiz | 1-10 min |
|
|
|
| Secondary | Gaze Metrics | total area of eye gaze seen, Extracted from eye-camera recording from the HoloLens 2 | total area of interest traveled by eye gaze on endoscopic monitor as measured by hololens | Posted | Mean | Standard Deviation | cm2 | 1-10 min |
|
|
|
| Secondary | Completion Time | Time for the stone identification task | Posted | Mean | Standard Deviation | seconds | 1-10 min |
|
|
|
| Secondary | NASA Task Load Index | 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. | 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. | Posted | Oct 2025 | Mean | Standard Deviation | nasa task load index score | 1 min |
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |