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

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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.