Status:
COMPLETED
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
Lead Sponsor:
Cook Research Incorporated
Conditions:
Esophageal Diseases
Eligibility:
All Genders
Brief 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).
Detailed Description
Cook Evolution® Esophageal Stent Post-Market Data Collection Study A retrospective observational, multi-center, chart review study will be performed. Data specific to Cook Evolution® Esophageal Stent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2023
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT05182255
Start Date
April 28 2022
End Date
December 8 2023
Last Update
February 12 2025
Active Locations (5)
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1
Klinikum Altenburg
Altenburg, Germany, 04600
2
Universitatsklinikum Augsburg
Augsburg, Germany, 86156
3
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
4
Hospital Universitario de Salamanca
Salamanca, ESP, Spain, 370007