Clinical Trial: Removal of the Evolution® Esophageal Stent - Fully Covered

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

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.

Detailed Summary:
Sponsor: Cook

Current Primary Outcome: Successful removal of study stent [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Cook

Dates:
Date Received: July 1, 2013
Date Started: September 2013
Date Completion: October 2018
Last Updated: March 16, 2017
Last Verified: February 2017