Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Study Overview
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Brief Summary
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This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Official Title
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A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Conditions
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Biliary Strictures Caused by Malignant Neoplasms

Intervention / Treatment
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* Device: WallFlex™ Biliary Partially-Covered Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Inoperable extrahepatic biliary obstruction by any malignant process Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms Willing and able to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: Participation in another invesitgational study within 90 days prior to date of patient consent. Strictures that cannot be dialated enough to pass the delivery system Perforation of any duct within the biliary tree Presence of any esophageal or duodenal stent Patients for whom endoscopic procedures are contraindicated Patients with known senesitivity to any components of the stent or delivery system Patients with active hepatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WallFlex Stent<br>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. | Device: WallFlex™ Biliary Partially-Covered Stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months post treatment or prior to death, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From time participant signs informed consent until time participant exits study (up to 6 months following stent placement) | 
| 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 | Initial stent placement procedure | 
| 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. | Up to 6 months post-initial study treatment | 
| Change in Biliary Obstruction Symptoms | Incidence of symptoms of biliary obstruction | up to 6 months post-initial study treatment | 
| 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. | Up to 6 months | 
| Change in Bilirubin | Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline. | 1 month following stent placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary, Strictures, Malignant, Neoplasm, Palliation