Clinical trial NCT02104076: Evolution® Biliary Stent System-Fully Covered
Official title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinomas/Neoplasms
Keywords: Bile Duct Obstructions
Biliary Stases
Biliary Tract
Stents
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention
timeFrame: 6 months
measure: Total Serum Bilirubin ≤ 3.0 mg/dL
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de 1'Université
state: Quebec
city: Lyon Cedex 03
country: France
facility: Hôpital Edouard Herriot
city: Nice Cedex 03
country: France
facility: Hôpital L'Archet 2
city: Rotterdam
country: Netherlands
facility: Erasmus Medish Centrum
Study officials:
affiliation: University of Colorado, Denver
name: Raj Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medish Centrum
name: Marco Bruno, M.D.
role: PRINCIPAL_INVESTIGATOR
References: