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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).
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 placement procedures from all consecutive patients who underwent stent placement with any of the stents at the participating sites between 1st January 2015 and 31st December 2020 (index period) will be collected. Research on the commercially available Cook Evolution® Esophageal Stents is being conducted to comply with the new medical device regulation, EU 2017/745, to assess the device for its continued safety and performance. To do this, Cook Research Incorporated is working with participating hospitals to collect pseudonymized (coded) personal health data. This study is in the interest of public health; to learn more about the necessary data processing, please visit the webpage below. https://www.cookresearchinc.com/extranet/pdf/2054-55\_Data\_Protection\_Notice.pdf Spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55\_Data\_Protection\_Notice\_ESP.pdf
Age
All ages
Sex
ALL
Healthy Volunteers
No
Klinikum Altenburg
Altenburg, Germany
Universitatsklinikum Augsburg
Augsburg, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Hospital Universitario de Salamanca
Salamanca, ESP, Spain
University College London
London, United Kingdom
Start Date
April 28, 2022
Primary Completion Date
December 8, 2023
Completion Date
December 8, 2023
Last Updated
February 12, 2025
127
ACTUAL participants
Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
DEVICE
Lead Sponsor
Cook Research Incorporated
NCT06315179
NCT05624099
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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