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

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ClinicalTrials.gov Identifier: NCT01900691
Recruitment Status : Recruiting
First Posted : July 16, 2013
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

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.

Condition or disease Intervention/treatment Phase
Esophageal Fistula Esophageal Neoplasms Esophageal Perforation Esophageal Stenosis Stents Device: Evolution® Esophageal Stent - Fully Covered Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
Study Start Date : September 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Successful removal of study stent [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Clinical success [ Time Frame: 7 days ]
  2. Dysphagia [ Time Frame: 0 - 6 months ]
  3. Incidence of procedural- and/or device-related adverse events [ Time Frame: 0 - 6 months ]
  4. Incidence of stent removal-related adverse events [ Time Frame: 30 days post-removal ]
  5. Device integrity during the stent removal procedure [ Time Frame: At stent removal (up to 6 months) ]
  6. Technical success [ Time Frame: at the end of the stent placement procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900691


Contacts
Contact: Levi Kosta-Mikel 765-463-7537 Levi.Kosta-Mikel@Cookmedical.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
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 Completed
Louisville, Kentucky, United States, 40202
United States, Mississippi
University of Mississippi Medical Center Completed
Jackson, Mississippi, United States, 39216
United States, Ohio
Cleveland Clinic Completed
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University Completed
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Methodist Dallas Medical Center Completed
Dallas, Texas, United States, 75203
United States, Virginia
University of Virginia Health System Completed
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: John Vargo, M.D., M.P.H. The Cleveland Clinic

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01900691     History of Changes
Other Study ID Numbers: 11-012
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Cook Group Incorporated:
Esophageal Fistula
Esophageal Neoplasms
Esophageal Perforation
Esophageal Stenosis
Stents

Additional relevant MeSH terms:
Esophageal Diseases
Fistula
Esophageal Neoplasms
Esophageal Stenosis
Esophageal Fistula
Esophageal Perforation
Pathological Conditions, Anatomical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Digestive System Fistula
Wounds and Injuries