EUS Procedures Using RIVOS™ EUS Access Device

Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device

This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.

Endoscopic ultrasound (EUS)-guided interventions are becoming the first-line treatment of various pancreaticobiliary disorders such as malignant biliary obstruction, access to bile duct or pancreatic duct after failed ERCP, and drainage of pancreatic, peripancreatic or intraabdominal fluid collections. However, given the lack of dedicated devices for performing these complex interventions, accessories used to perform endoscopic retrograde cholangiopancreatography (ERCP) are currently being used off-label to perform most interventional EUS procedures.

The RIVOS™ EUS access device is a novel, FDA approved device that has been specifically developed for performing EUS-guided interventions. The device has a sharp trocar tip to allow access to the target organ, a flexible access cannula to allow contrast injection and passage of a guidewire, and an electrocautery-tip to facilitate the creation of a fistula. This innovative design is expected to simplify the technical aspects of the procedure and improve the safety profile for these complex endoscopic interventions.

The aim of this study is to evaluate the technical and treatment outcomes in patients undergoing standard of care, interventional EUS-guided procedures in patients with pancreaticobiliary disorders using the RIVOS™ EUS access device.

Inclusion Criteria:

• Age ≥ 18 years
• All patients undergoing EUS-guided interventions using the RIVOS™ EUS access device

Exclusion Criteria:

• Age < 18 years
• Patients who did not undergo EUS-guided interventions using the RIVOS™ EUS access device