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WallFlex Biliary RX Fully Covered Stent System · 1 trial · 1 indication
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...
WallFlex Biliary RX Fully Covered Stent System is used for biliary stricture, a narrowing of the bile duct. It is a fully covered stent designed to be placed in the bile duct to keep it open. The device is being studied in a clinical trial for this condition.
WallFlex Biliary RX Fully Covered Stent System is developed by Boston Scientific Corporation, a medical device company. Boston Scientific is publicly traded under the ticker symbol BSX on the New York Stock Exchange.
WallFlex Biliary RX Fully Covered Stent System is in Phase 3 clinical development. It is an investigational device, meaning it has not yet been approved for general use. The Phase 3 study has been completed.
WallFlex Biliary RX Fully Covered Stent System has one completed Phase 3 clinical trial, identified as NCT01014390. This study, titled WallFlex Biliary Fully Covered (FC) Benign Stricture Study, enrolled 187 participants with biliary stricture across multiple countries including Australia, Austria, Belgium, Canada, Chile, France, Germany, India, Italy, Netherlands, and Spain.
WallFlex Biliary RX Fully Covered Stent System is the full name of the device, and it is also referred to as WallFlex Biliary Fully Covered Stent in the clinical trial title. The study NCT01014390 is called the WallFlex Biliary Fully Covered (FC) Benign Stricture Study, indicating these names refer to the same stent system.