Evaluation of the RIVOS EUS Access Device for Endoscopic Ultrasound Procedures in Pancreaticobiliary Disorders

What this Trial Is About

This research aims to evaluate the use of the RIVOS EUS access device in patients with pancreaticobiliary disorders such as malignant biliary obstruction, pancreatic duct obstruction, chronic pancreatitis, and pancreatic cancer that cannot be surgically removed. The study focuses on interventional procedures guided by endoscopic ultrasound EUS, which are increasingly used for these conditions. Currently, devices intended for other procedures are used off-label, so this study assesses a new device specifically designed for EUS-guided interventions. The RIVOS EUS access device is a novel, FDA-approved tool featuring a sharp trocar tip for organ access, a flexible cannula for contrast injection and guidewire passage, and an electrocautery tip to aid fistula creation. The study involves patients undergoing standard care interventional EUS procedures using this device. The study period runs from July 2026 to December 2027. Participants will undergo EUS-guided interventions using the RIVOS device, with technical success measured within 1 day after the procedure. Researchers will also monitor treatment success, adverse events, procedure duration, and hospital admissions over 4 weeks. This observational study collects data on outcomes and safety to better understand the devices role in managing pancreaticobiliary disorders.

EUS Procedures Using RIVOS™ EUS Access Device