| Primary | Number of Participants With Absence of Recurrent Biliary Obstruction | Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points. | | Posted | | Count of Participants | | Participants | | Up to 6 months post treatment or prior to death, whichever came first | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Number of Adverse Events Related to the Device and/or Procedure | Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints. | | Posted | | Number | | related adverse events | | From time participant signs informed consent until time participant exits study (up to 6 months following stent placement) | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Number of Participants With Technical Stent Placement Success | Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture | | Posted | | Count of Participants | | Participants | | Initial stent placement procedure | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Number of Participants With Occurrence of Re-intervention | A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture. | | Posted | | Count of Participants | | Participants | | Up to 6 months post-initial study treatment | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Change in Biliary Obstruction Symptoms | Incidence of symptoms of biliary obstruction | | Posted | | Mean | Standard Deviation | count of symptoms | | up to 6 months post-initial study treatment | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Time to Recurrent Biliary Obstruction | Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded. | | Posted | | Mean | Standard Deviation | days | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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| Secondary | Change in Bilirubin | Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline. | | Posted | | Mean | Standard Deviation | mg/dL | | 1 month following stent placement | | | | ID | Title | Description |
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| OG000 | WallFlex Stent | All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted. WallFlex™ Biliary Partially-Covered Stent: Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent. |
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