This trial is active, not recruiting.

Condition carcinomas/neoplasms
Treatment evolution® biliary stent-fully covered
Sponsor Cook
Start date September 2014
End date July 2016
Trial size 90 participants
Trial identifier NCT02104076, 10-014


The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
evolution® biliary stent-fully covered
Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

Primary Outcomes

Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
time frame: 6 months
Total Serum Bilirubin ≤ 3.0 mg/dL
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent Exclusion Criteria: - < 18 years of age - Unwilling or unable to sign and date the informed consent - Unwilling or unable to comply with the follow-up schedule - Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources - Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment - Endoscopic procedures are contraindicated - Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms - Presence of a metal biliary stent - Presence of an esophageal or duodenal stent - Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated - Coagulopathy - Diffuse intrahepatic metastases that involves > 10 % of the liver - Life expectancy of < 3 months - Pregnant - Active alcohol or substance abuse issue - Jaundice secondary to a cause other than biliary duct obstruction - Additional endoscopic restrictions as specified in the Clinical Investigation Plan

Additional Information

Official title Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
Principal investigator Raj Shah, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Cook.
Location data was received from the National Cancer Institute and was last updated in August 2016.