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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EB035783-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| Vanderbilt University | OTHER |
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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.
Specifically for this study, the investigators are asking surgical trainees and experts to wear the HoloLens 2 in the a kidney stone identification phantom study. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR guided | Experimental | Trainees can see experts' gaze through the HoloLens |
|
| Non-AR guided | No Intervention | Trainees cannot see experts' gaze through the HoloLens. This should be the standard of care control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented reality | Device | Augmented reality markers show the surgical trainee the expert's gaze location during the kidney exploration phase of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of Kidney Exploration | Percentage of kidney that was visualized | up to 24 hours after the study was completed by the participant |
| Measure | Description | Time Frame |
|---|---|---|
| Gaze Path of the User While Performing Kidney Exploration | Extracted from eye-camera recording from the HoloLens 2, total gaze path seen | up to 24 hours after experiment completed by the participant |
| Completion Time |
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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 data will be uploaded to the NIDDK repository by Aug 2026. We foresee the data being available indefinitely.
Access to individual data will be controlled through the NIDDK repository and available only for research purposes.
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| ID | Title | Description |
|---|---|---|
| FG000 | AR Guided | Trainees can see experts' gaze through the HoloLens |
| FG001 | Non-AR Guided | Trainees cannot see experts' gaze through the HoloLens. This should be the standard of care control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
this is number of participants in each group
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| ID | Title | Description |
|---|---|---|
| BG000 | AR Guided | Trainees can see experts' gaze through the HoloLens |
| BG001 | Non-AR Guided | Trainees cannot see experts' gaze through the HoloLens. This should be the standard of care control group. |
| 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 in 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 | Completeness of Kidney Exploration | Percentage of kidney that was visualized | Posted | Mean | Standard Deviation | percentage of kidney seen | up to 24 hours after the study was completed by the participant |
|
|
up to 24 hours after experiment completed by the participant
these were residents doing a phantom study ex vivo.
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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 Guided | Trainees can see experts' gaze through the HoloLens | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Kavoussi,MD | Vanderbilt University | 615-322-2880 | 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 | Apr 28, 2026 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2025 | Apr 28, 2026 | ICF_002.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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Time for the stone identification task
| up to 24 hours after experiment completed by the participant |
| Stone Count | Number of stones seen | up to 24 hours after experiment completed by the participant |
| BG002 | Total | Total of all reporting groups |
| Full Range |
| years |
|
| Sex: Female, Male | gender, binary male or female | Count of Participants | Participants |
|
| Race (NIH/OMB) | race total count | Count of Participants | Participants |
|
| Region of Enrollment | residents at vanderbilt university medical center in nashville | Number | Participants |
|
| Participants |
|
|
| Secondary | Gaze Path of the User While Performing Kidney Exploration | Extracted from eye-camera recording from the HoloLens 2, total gaze path seen | Posted | Mean | Standard Deviation | cm | up to 24 hours after experiment completed by the participant |
|
|
|
| Secondary | Completion Time | Time for the stone identification task | Posted | Mean | Standard Deviation | seconds | up to 24 hours after experiment completed by the participant |
|
|
|
| Secondary | Stone Count | Number of stones seen | Posted | Number | number of stones | up to 24 hours after experiment completed by the participant |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Non-AR Guided | Trainees cannot see experts' gaze through the HoloLens. This should be the standard of care control group. | 0 | 5 | 0 | 5 | 0 | 5 |
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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 |