Neoplasms Clinical Trial
Official title:
Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
Verified date | April 2015 |
Source | Cook |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l' Universite de Montreal (CHUM) | Montreal | Quebec |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | The Pancreas and Biliary Center of South Florida | Boca Raton | Florida |
United States | Borland-Groover Clinic | Jacksonville | Florida |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Florida Hospital | Orlando | Florida |
United States | SUNY at Stony Brook Hospital | Stony Brook | New York |
United States | University of Massachusetts Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cook |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from symptomatic recurrent biliary obstruction requiring reintervention | 6 months | No | |
Secondary | Technical success | Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure. | Immediately following completion of the stent placement procedure | No |
Secondary | Incidence of device-related adverse events | 6 months | Yes | |
Secondary | Ease of use | Ease of use will be evaluated on a five point scale ranging from very easy to very difficult. | Immediately following completion of the stent placement procedure | No |
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