Trial record 5 of 8 for:    cholangiocarcinoma | United States, North Carolina

Evolution® Biliary Stent System-Fully Covered

This study is not yet open for participant recruitment.
Verified April 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT02104076
First received: April 2, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

The Evolution® Biliary Stent System-Fully Covered is a clincial trial to study the effectiveness of the Evolution® Biliary Stent-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.


Condition Intervention
Carcinomas
Common Bile Duct Neoplasm
Cholangiocarcinoma
Device: Fully Covered Biliary Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation fo the Effectiveness of Evolution® Biliary Stent System-Fully Covered

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • percentage of patients free from symptoms of biliary obstruction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: October 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fully Covered Biliary Stent Device: Fully Covered Biliary Stent
Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a biliary stent

Exclusion Criteria:

  • < 18 years of age
  • Unwilling or unable to sign and date the informed consent
  • Undergone or is planning to under go brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
  • Participating in another investigational drug or device study in which 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
  • Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medicaton required to complete the procedure
  • 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 Clnical Investigation Plan

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02104076

Contacts
Contact: Travis Conley, PhD 765-463-7537 tconley@medinst.com
Contact: Malin Tygesen +45 56868572 Malin.Tygesen@CookMedical.com

Locations
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Lindsay Hosford       Lindsay.hosford@UCdenver.edu   
Principal Investigator: Raj Shah, M.D.         
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Jason Klapman, M.D.         
United States, Indiana
Indiana University Hospital Not yet recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Lee McHenry, M.D.         
United States, Massachusetts
Beth Israel Deaconess Medcial Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Ram Chuttani, M.D.         
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: John Evans, M.D.         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Adam Slivka, M.D.         
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Gary May, M.D.         
Canada, Quebec
Centre Hospitalier de 1'Universite Not yet recruiting
Montreal, Quebec, Canada, H2W 1T8
Principal Investigator: Andre Roy, M.D.         
France
Hospital Edouard Herriot Not yet recruiting
Lyon Cedex 03, France, 69437
Principal Investigator: Thierry Ponchon, M.D.         
Institut Paoli-Calmettes Not yet recruiting
Marseille, France, 13273
Principal Investigator: Marc Giovannini, M.D.         
Hopital L'Archat 2 Not yet recruiting
Nice Cedex 03, France, 23079
Principal Investigator: Geoffroy Vanbiervliet, M.D.         
Italy
Presidio Ospedaliero Bellaria-Maggiore Not yet recruiting
Bologna, Italy, 40139
Principal Investigator: Vincenzo Cennamo, Prof         
Netherlands
Erasmus Medish Centrum Not yet recruiting
Rotterdam, Netherlands, 3015
Principal Investigator: Marco Bruno, M.D.         
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Raj Shah, M.D. University of Colorado Hospital
Principal Investigator: Marco Bruno, M.D. Erasmus Medish Centrum
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT02104076     History of Changes
Other Study ID Numbers: 10-014
Study First Received: April 2, 2014
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency

Keywords provided by Cook:
Bile Duct Obstructions
Biliary Stases
Biliary Tract
Stents

Additional relevant MeSH terms:
Cholangiocarcinoma
Bile Duct Neoplasms
Neoplasms
Carcinoma
Common Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Common Bile Duct Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on April 16, 2014