Symptoms and General Pathology

All Conditions

Digestive System Diseases

Constriction, Pathologic

Cholestasis

Pathological Conditions, Anatomical

Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

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.

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.

WallFlex™ Biliary Partially-Covered Stent

Robert Walsh, M.D.

Guido Costamagna, M.D.

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.

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

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

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.

Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture

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.

Incidence of symptoms of 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.

Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.

Boston Scientific Corporation

Reported on Adverse Events (Serious and Non-serious) related to the device and/or procedure.

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.

WallFlex Stent

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Malignant cause of bile duct stricture

Stricture location

number of 60mm x10mm stents placed

number of 40mm x 10mm stents placed

number of 80mm x10mm stents placed

number of 60mm x 8mm stents placed

A total of 71 stents were placed, as two of the study participants required two stents to be placed due to the length of their strictures.

Number of study stents placed

70 patients were enrolled, of whom 69 received a stent and were evaluated for baseline characteristics.

Spots Global Cancer Trial Database for Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial