An observational study in Pancreatic Fluid Collections, Biliary Obstruction and Pancreatic Duct Obstruction, sponsored by Orlando Health, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Orlando Health, Inc. · Observational
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.
264 studies on the registry are indexed under Pancreatitis, Chronic; 73 are open to participants now.
This study's planned enrollment of 30 is below the median of 300 across 114 observational studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →Orlando Health, Inc. is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing EUS-guided interventions
Exclusion Criteria:
Patients requiring interventional EUS procedures
Device: EUS-guided intervention using the RIVOS™ EUS access device
EUS-guided intervention using the RIVOS™ EUS access device
Technical success
Rate of technical success in patients undergoing EUS-guided procedures
Time frame: 1 day
Treatment success
Rate of treatment success, defined as the resolution of symptoms and/or radiological findings from underlying disease at 4-weeks following index intervention.
Time frame: 4 weeks
Adverse events
Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
Time frame: 4 weeks
Procedure duration
Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.
Time frame: 1 day
Hospital admission
Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.
Time frame: 4 weeks
Plan to share: No
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Orlando Health, Inc.