Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01014390 | WallFlex Biliary Fully Covered (FC) Benign Stricture Study | PHASE3 | COMPLETED | 187 | — | — | Dec 1, 2009 | Nov 1, 2017 | Feb 19, 2020 | 13 | Australia, Austria +9 |
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
| Arm | Type | Description |
|---|---|---|
| WallFlex Biliary RX FC Stent System | EXPERIMENTAL | The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures. |
| Name | Type | Description |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System | DEVICE | Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients. |
Inclusion Criteria: * Age 18 or older * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy) * Indicated for ERCP proc...