Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator

虚拟减肥内窥镜（ViBE）模拟器的开发和验证 摘要 内窥镜袖状胃成形术（ESG）正在迅速成为数百万人的可行的非手术选择， 3级肥胖（体重指数[BMI] ≥ 40 kg/m2）或2级肥胖（BMI 35至<40）患者， 多次尝试饮食和生活方式改变失败但无法接受 减肥手术由于其成本，风险和获得护理。ESG是一种经口柔性内窥镜技术 其通过从胃腔内排出而显著减小胃的体积。研究 已经证明，这是一种安全和可重复的程序，与显着持久的体重减轻有关 和减少与肥胖相关的共病。然而，学习执行ESG在技术上是 要求达到基本熟练程度所需的最低35例。因为ESG要求 使用专门的FDA批准的内窥镜活检系统进行复杂操作， 缝合 在以患者为中心的环境、社会和管治之外， 医学和程序教育的学徒模式，预计将基于虚拟现实（VR） 具有视觉和触觉反馈的培训师将对ESG培训非常宝贵，使学员能够获得 在受控环境中的能力，对患者没有风险;实现定制学习;并提供 真实的时间反馈、指导和客观评估。本提案的目标是设计， 开发并验证虚拟减肥内窥镜（ViBE）模拟器，可用于培训 内窥镜减肥手术，如ESG。已经组建了一个多学科小组， 具体目标如下：（SA 1）为ViBE开发视觉和触觉环境：具体而言，我们 将开发（1）ESG中涉及的高度逼真的3D解剖和工具模型，以及（2）触觉硬件 用于临床医生与虚拟患者解剖结构无缝交互的界面。(SA（2）发展物理 ViBE的仿真环境：具体来说，我们将（1）开发基于真实物理的实时 仿真的ESG程序，包括一个新的约束样条动力学（CSD）算法， 内窥镜手术的建模，（2）进行体内内窥镜手术研究，以提供设计 规范的触觉接口，并验证计算模型，（3）制定指标的任务 表现和目标分数，这将作为学习的终点和（4）发展一个智能 认知助理，将提供识别错误的实时反馈以及视觉和听觉提示 来指导学员(SA 3）建立ViBE作为培训工具的有效性和实用性：我们将 对自愿登记的参与者进行实验，以确保在他们的基础上学习适当的技能。 ViBE和在ViBE上测量的性能反映了适当的技术技能。此外，我们将 研究ViBE上的培训是否上级离体猪标本上的培训，并积极转移到 临床设置。

Development and Validation of a Virtual Bariatric Endoscopic (ViBE) Simulator Abstract Endoscopic Sleeve Gastroplasty (ESG) is rapidly emerging as a viable non-surgical option to millions of patients with Class 3 Obesity (Body Mass Index [BMI] ≥ 40 kg/m2) or Class 2 Obesity (BMI 35 to <40) with comorbidities who have failed multiple attempts at diet and lifestyle changes but are unable to undergo bariatric surgery due to its cost, risk and access to care. ESG is a trans-oral flexible endoscopy technique which significantly reduces the volume of the stomach by suturing it from within the gastric lumen. Studies have shown that it is a safe and reproducible procedure that is associated with significant durable weight loss and reduction of co-morbidities associated with obesity. However, learning to perform ESG is technically demanding with a minimum of 35 cases necessary to attain basic proficiency. This is because ESG requires complex maneuvers using a specialized FDA-approved endoscopic suturing system to apply full-thickness sutures. With no formal curriculum or competency standards in place for ESG outside the patient-centric apprenticeship model of medical and procedural education, it is anticipated that a virtual reality (VR)-based trainer, with visual and haptic (touch) feedback, will be invaluable for training in ESG, allowing trainees to attain competence in a controlled environment with no risk to patients; to enable customized learning; and to offer real time feedback, mentoring and objective assessment. The goal of the present proposal is to design, develop and validate a Virtual Bariatric Endoscopic (ViBE) simulator that can be used to train endoscopic bariatric procedures such as ESG. A multidisciplinary team has been assembled to achieve the following Specific Aims: (SA 1) Develop the visual and haptic environment for the ViBE: Specifically, we will develop (1) highly realistic 3D anatomical and tool models involved in ESG, and (2) haptic hardware interface for the clinician to interact seamlessly with the virtual patient anatomy. (SA 2) Develop the physical simulation environment for the ViBE: Specifically, we will (1) develop realistic physics-based real-time simulations of the ESG procedure including a novel constrained spline dynamics (CSD) algorithm for modeling of endoscopic suturing, (2) perform in vivo endoscopic suturing studies to provide design specifications for the haptic interface and to validate the computational models, (3) develop metrics of task performance and goal scores which will serve as end points of learning and (4) develop an intelligent cognitive assistant that will provide real-time feedback identifying errors as well as visual and auditory cues to guide the trainee. (SA 3) Establish the validity and usefulness of the ViBE as a training tool: We will conduct experiments on voluntarily enrolled participants to ensure that appropriate skills are being learned on the ViBE and performance measured on the ViBE reflects the appropriate technical skills. Further, we will study if training on the ViBE is superior to training on ex vivo porcine specimens, and transfers positively to the clinical setting.