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