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临床试验/NCT07161024
NCT07161024已完成不适用

AR Projections for Eye-gaze Evaluation in Phantoms

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年10月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Stone Count

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Urology residents at Vanderbilt University Medical Center

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Augmented reality (Device)

结局指标

主要结局

Stone Count

时间窗: 1-10 min

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.

NASA Task Load Index

时间窗: 1 m in

Conducted after each trial for subjective feedback

次要结局

  • Gaze Metrics(1-10 min)
  • Completion Time(1-10 min)
  • NASA Task Load Index(1 min)
  • Kidney exploration(1-10 min)
  • Stone count(1-10 min)
  • Gaze metrics(1-10 min)
  • Completion time(1-10 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Kavoussi

Assistant Professor Department of Urology

Vanderbilt University Medical Center

研究点 (1)

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