Clinical trial NCT01962168: Evolution® Biliary Stent System Clinical Study
Official title: Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Neoplasms
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract
Stents
Keywords: Biliary Tract Neoplasms
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Biliary Tract
Stents
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for biliary stent placement based on institutional guidelines and product IFU.

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.


Eligibility criteria: Inclusion Criteria:

* Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Freedom from symptomatic recurrent biliary obstruction requiring reintervention
timeFrame: 6 months
Secondary outcomes:
measure: Technical success
timeFrame: Immediately following completion of the stent placement procedure
measure: Incidence of device-related adverse events
timeFrame: 6 months
measure: Ease of use
timeFrame: Immediately following completion of the stent placement procedure
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Boca Raton
country: United States
facility: The Pancreas and Biliary Center of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Stony Brook
country: United States
facility: SUNY at Stony Brook Hospital
state: New York
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Montreal
country: Canada
facility: Centre Hospitalier de l' Universite de Montreal (CHUM)
state: Quebec
Study officials:
affiliation: Summerville GI & Advanced Endoscopy
name: Christopher Lawrence
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.