First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study

Since its emergence in the 1980s, endoscopic ultrasound (EUS) is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal (GI) disorders. Despite its utility, the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts. EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation, as well as extensive knowledge of intraabdominal anatomy. The aim of the APEUS (Augmented Pancreatic Endoscopic UltraSound) project is to overcome these two main difficulties by providing a Global Positioning System (GPS)-like intraoperative navigation for EUS procedures, using a 3D-based model on registered preoperative data. The hypothesis is that, thanks to this tool, the procedures time would be shortened, and the pancreas and its lesions would be completely imaged. This would reduce the demand for experts guiding trainees and shorten the EUS learning curve. This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution. The primary objective is to evaluate the EUS navigation system's procedure duration compared to standard procedure times (patient group with the EUS-GPS system vs control group without).