Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Cov… (NCT05182255) | Clinical Trial Compass
CompletedNot Applicable
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
Germany, Spain, United Kingdom127 participantsStarted 2022-04-28
Plain-language summary
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1: Patient has had at least one of the following stents implanted between 1st January 2018 and 31st December 2020\*:
* Evolution® Esophageal Stent System-Partially Covered
* Evolution® Esophageal Stent System-Fully Covered
* Evolution® Esophageal Stent System-Fully Covered
Exclusion Criteria:
1: Deceased retrospective patient who has set post-mortem instruction against processing of his/her health data
2\. Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to sign not willing to sign an Informed consent, if it is required by the local EC committee. There may be local exemptions where consent is not a requirement or non-objection letters may replace informed consent processes.
What they're measuring
1
Number of participants with clinically relevant device migration