Evolution® Biliary Stent System Clinical Study

• Sponsor: Cook Group Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01962168
• Collaborator: (none)
• Enrollment: 113
• Locations: 9
• Duration (Months): 14.9
• Patients Per Site: 12.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Neoplasms; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Biliary Tract; Stents	Device: Evolution® Biliary Stent - Uncovered

Study Design

• Study Type: Observational
• Actual Enrollment: 113 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Evolution® Biliary Stent - Uncovered	Device: Evolution® Biliary Stent - Uncovered; Commercially available device

Outcome Measures

Primary Outcome Measures

1. Freedom from symptomatic recurrent biliary obstruction requiring reintervention [6 months]

Secondary Outcome Measures

1. Technical success [Immediately following completion of the stent placement procedure]

   Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure.

2. Incidence of device-related adverse events [6 months]

3. Ease of use [Immediately following completion of the stent placement procedure]

   Ease of use will be evaluated on a five point scale ranging from very easy to very difficult.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Infirmary Medical Center	Mobile	Alabama	United States	36607
2	The Pancreas and Biliary Center of South Florida	Boca Raton	Florida	United States	33486
3	Borland-Groover Clinic	Jacksonville	Florida	United States	32256
4	Florida Hospital	Orlando	Florida	United States	32803
5	Northwest Community Hospital	Arlington Heights	Illinois	United States	60005
6	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
7	SUNY at Stony Brook Hospital	Stony Brook	New York	United States	11794
8	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
9	Centre Hospitalier de l' Universite de Montreal (CHUM)	Montreal	Quebec	Canada	H2X 3J4

Sponsors and Collaborators

• Cook Group Incorporated

Investigators

• Principal Investigator: Christopher Lawrence, Summerville GI & Advanced Endoscopy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cook Group Incorporated
• ClinicalTrials.gov Identifier: NCT01962168
• Other Study ID Numbers: 12-009
• First Posted: Oct 14, 2013
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Cook Group Incorporated: Biliary Tract Neoplasms; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Biliary Tract; Stents
• Additional relevant MeSH terms: Neoplasms; Biliary Tract Neoplasms; Gastrointestinal Diseases; Digestive System Diseases

Study Results

No Results Posted as of Apr 8, 2015