Removal of the Evolution® Esophageal Stent - Fully Covered (CLARITY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Cook
Information provided by (Responsible Party):
Cook Identifier:
First received: July 1, 2013
Last updated: February 9, 2016
Last verified: December 2015
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.

Condition Intervention
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Device: Evolution® Esophageal Stent - Fully Covered

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Successful removal of study stent [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical success [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Dysphagia [ Time Frame: 0 - 6 months ] [ Designated as safety issue: No ]
  • Incidence of procedural- and/or device-related adverse events [ Time Frame: 0 - 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of stent removal-related adverse events [ Time Frame: 30 days post-removal ] [ Designated as safety issue: Yes ]
  • Device integrity during the stent removal procedure [ Time Frame: At stent removal (up to 6 months) ] [ Designated as safety issue: Yes ]
  • Technical success [ Time Frame: at the end of the stent placement procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolution® Esophageal Stent Device: Evolution® Esophageal Stent - Fully Covered
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01900691

Contact: Cory Hultman 765-463-7537

United States, California
Harbor-University of California Los Angeles Medical Center Recruiting
Torrance, California, United States, 90502-2004
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Loyola University Medical Center Completed
Maywood, Illinois, United States, 60153
United States, Kentucky
University of Louisville, Division of Surgical Oncology Recruiting
Louisville, Kentucky, United States, 40202
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Principal Investigator: John Vargo, M.D., M.P.H. The Cleveland Clinic
  More Information

Responsible Party: Cook Identifier: NCT01900691     History of Changes
Other Study ID Numbers: 11-012 
Study First Received: July 1, 2013
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Digestive System Diseases
Digestive System Fistula
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pathological Conditions, Anatomical
Wounds and Injuries processed this record on April 27, 2016