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This is a prospective study of patients undergoing EUS procedures using the RIVOSâ„¢ 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 RIVOSâ„¢ 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 RIVOSâ„¢ EUS access device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients requiring interventional EUS procedures | Patients requiring interventional EUS procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided intervention using the RIVOSâ„¢ EUS access device | Device | EUS-guided intervention using the RIVOSâ„¢ EUS access device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Rate of technical success in patients undergoing EUS-guided procedures | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing EUS-guided interventions
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Young Bang, MD MPH | Contact | 321-842-2273 | jiyoung.bang@orlandohealth.com | |
| Barbara J Broome | Contact | 321-841-3742 | barbara.broome@orlandohealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health Digestive Health Institute | Recruiting | Orlando | Florida | 32806 | United States |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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Rate of adverse events, procedure-related and disease-related, in patients undergoing endoscopic ultrasound procedures.
| 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. | 1 day |
| Hospital admission | Rate of hospital admission due to disease-related symptoms or procedure-related adverse events. | 4 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |