EUS Procedures Using RIVOS™ EUS Access Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EUS-guided intervention using the RIVOS™ EUS access device.
- Who it may be relevant to
- Registry conditions: Pancreatic Fluid Collections, Biliary Obstruction, Pancreatic Duct Obstruction, Chronic Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Registry of Patients Undergoing Endoscopic Ultrasound (EUS) Procedures Using the RIVOS™ EUS Access Device
Overview
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.
Detailed description
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.
Interventions
- Device EUS-guided intervention using the RIVOS™ EUS access device
EUS-guided intervention using the RIVOS™ EUS access device
Primary outcome measures
- Technical success [Time frame: 1 day]
Secondary outcome measures (4)
- Treatment success [Time frame: 4 weeks]
- Adverse events [Time frame: 4 weeks]
- Procedure duration [Time frame: 1 day]
- Hospital admission [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Orlando Health Digestive Health Institute — Orlando
Identifiers
NCT: NCT07696572 · 2457590