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 Obesity is a chronic, relapsing, multifactorial, and neurobehavioral disease that requires life-long, multidisciplinary management beyond a single intervention. The current treatment options for patients with morbid obesity include pharmacotherapy, which only induces suboptimal weight loss, and bariatric surgery, utilized only by a small fraction of the eligible patients. Endoscopic Sleeve Gastroplasty (ESG) is rapidly emerging as a new tool to combat the obesity epidemic used both as (i) primary weight loss procedure and (ii) endoscopic revision for patients experiencing weight gain following surgery. It is a safe and effective, incision-less, non-surgical technique performed with a flexible endoscope, introduced through the mouth, which reduces the gastric volume by placing full-thickness sutures from within the gastric lumen. It is a one-day outpatient procedure with rapid return to work. However, learning to perform ESG is technically demanding, with a minimum of 35 cases necessary to attain basic proficiency. Though endoscopic suturing skills are critical for ESG, just learning endoscopic suturing is not sufficient for performing ESG. 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. Significant technical innovations of this project include (1) developing realistic physics-based real-time simulations of the ESG procedure, including an efficient constrained spline dynamics (CSD) algorithm for modeling endoscopic suturing, (2) an innovative hardware interface for accurate force feedback during ESG, (3) in vivo porcine experiments to characterize the endoscopic suturing procedure; and (4) a cognitive assistant module, based on detailed cognitive task analysis, to provide real-time feedback to the trainee. 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 test the hypothesis that trainees who train on the ViBE simulator will learn at the same rate or better than those trained on ex vivo porcine gastrointestinal specimens and that this training will transfer to the clinical environment. The significance of this project is that it focuses on the obesity epidemic and proposes to develop a simulator to enable the safe adoption of ESG. Endoscopic suturing skills learned on the ViBE will translate to other endoscopic procedures, e.g., stent fixation and management of bariatric surgical complications.