Evolution® Biliary Stent System Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Biliary Tract Neoplasms Neoplasms Gastrointestinal Diseases Digestive System Diseases Biliary Tract Stents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Evolution® Biliary Stent - Uncovered

Intervention Type DEVICE

Commercially available device

Interventions

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Evolution® Biliary Stent - Uncovered

Commercially available device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No