Orlando Health Digestive Health Institute
Orlando, Florida, 32806, United States
Location status: Recruiting
Location contact
Barbara J Broome
CONTACT
Ji Young Bang, MD MPH
CONTACT
Ji Young Bang, MD MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07696572
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Orlando, Florida, 32806, United States
Location status: Recruiting
Barbara J Broome
CONTACT
Ji Young Bang, MD MPH
CONTACT
Ji Young Bang, MD MPH
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EUS-guided intervention using the RIVOS™ EUS access device
Time frame: 1 day
Rate of technical success in patients undergoing EUS-guided procedures
Time frame: 4 weeks
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
Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
Time frame: 1 day
Total procedure duration, defined as time taken from start of the EUS-procedure to time the echoendoscope is withdrawn from the patient.
Time frame: 4 weeks
Rate of hospital admission due to disease-related symptoms or procedure-related adverse events.
Contact information is provided by the study sponsor or research team.
Barbara J Broome
CONTACT
Ji Young Bang, MD MPH
CONTACT
Orlando Health, Inc.
Other
Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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