Clinical trial NCT01900691: Removal of the Evolution® Esophageal Stent - Fully Covered
Official title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Stents
Keywords: Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Stents
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
* Physician plans to remove the stent within the duration of study follow-up

Exclusion Criteria:

* Patient is \< 18 years of age
* Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
* Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
* Patient is simultaneously participating in another investigational drug or device study
* Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement
* Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated

Primary outcomes:
measure: Number of Patients With Successful Removal of Study Stent
timeFrame: 7 days to 6 months
Secondary outcomes:
measure: Number of Patients With Benign Indications That Achieved Clinical Success
timeFrame: 7 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Torrance
country: United States
facility: Harbor-University of California Los Angeles Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville, Division of Surgical Oncology
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: John Vargo, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: