Status:
COMPLETED
Removal of the Evolution® Esophageal Stent - Fully Covered
Lead Sponsor:
Cook Group Incorporated
Conditions:
Esophageal Fistula
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01900691
Start Date
September 1 2013
End Date
December 10 2018
Last Update
September 13 2022
Active Locations (11)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Harbor-University of California Los Angeles Medical Center
Torrance, California, United States, 90502-2004
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153