Removal of the Evolution® Esophageal Stent - Fully Covered
Conditions
Esophageal Fistula - Esophageal Neoplasms - Esophageal Perforation - Esophageal Stenosis - Stents
Conditions: official terms
Esophageal Fistula - Esophageal Neoplasms - Esophageal Perforation - Esophageal Stenosis
Conditions: Keywords
Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Evolution® Esophageal Stent - Fully Covered
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Harbor-University of California Los Angeles Medical Center
Torrance, California, United States
Status: Recruiting
Contact: Sofiya Reicher, MD - 310-222-2475
Emory University Hospital
Atlanta, Georgia, United States
Status: Recruiting
Loyola University Medical Center
Maywood, Illinois, United States
Status: Completed
University of Louisville, Division of Surgical Oncology
Louisville, Kentucky, United States
Status: Recruiting
Contact: Melissa Schlegel - 502-629-3383 - melissa.schlegel@louisville.edu
University of Mississippi Medical Center
Jackson, Mississippi, United States
Status: Recruiting
Contact: Shou Tang, MD - 601-984-4540 - stang@umc.edu
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Madhusudhan Sanaka, MD - 216-444-3423 - SANAKAM@ccf.org
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Cynthia Miller, RN - 215-955-8108 - Cynthia.miller@jefferson.edu
Methodist Dallas Medical Center
Dallas, Texas, United States
Status: Recruiting
Contact: Paul Tarnasky, MD - 214-941-6891 - Paul.tarnasky@dhat.com
University of Virginia Health System
Charlottesville, Virginia, United States
Status: Recruiting
Contact: Bryan Sauer, MD - 434-924-9582 - bryansauer@virginia.edu
Froedtert Hospital
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Kulwinder Dua, MD - 414-995-6804 - kdua@mcw.edu
Start Date
September 2013
Completion Date
July 2016
Sponsors
Cook
Source
Cook
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page