Evolution® Biliary Stent System Clinical Study
Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
1 other identifier
observational
113
2 countries
9
Brief Summary
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2013
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 8, 2015
April 1, 2015
1.2 years
October 9, 2013
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from symptomatic recurrent biliary obstruction requiring reintervention
6 months
Secondary Outcomes (3)
Technical success
Immediately following completion of the stent placement procedure
Incidence of device-related adverse events
6 months
Ease of use
Immediately following completion of the stent placement procedure
Study Arms (1)
Evolution® Biliary Stent - Uncovered
Interventions
Commercially available device
Eligibility Criteria
Candidates for biliary stent placement based on institutional guidelines and product IFU.
You may qualify if:
- Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.
You may not qualify if:
- Patient is less than 18 years of age.
- Patient is unable or unwilling to provide written informed consent.
- Patient is unable or unwilling to comply with the follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
The Pancreas and Biliary Center of South Florida
Boca Raton, Florida, 33486, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Florida Hospital
Orlando, Florida, 32803, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
SUNY at Stony Brook Hospital
Stony Brook, New York, 11794, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Centre Hospitalier de l' Universite de Montreal (CHUM)
Montreal, Quebec, H2X 3J4, Canada
Related Publications (1)
Lawrence C, Nieto J, Parsons WG, Roy A, Guda NM, Steinberg SE, Hasan MK, Bucobo JC, Nagula S, Dey ND, Buscaglia JM; Study Investigators. A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study. BMC Gastroenterol. 2020 Jun 10;20(1):184. doi: 10.1186/s12876-020-01325-9.
PMID: 32522161DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Lawrence
Summerville GI & Advanced Endoscopy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 14, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 8, 2015
Record last verified: 2015-04