Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered

Conditions
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Esophageal Diseases

Intervention / Treatment
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* Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophageal Stent Systems<br>Freedom from endoscopic re-intervention due to recurrence of dysphagia | Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered<br>* To aid in maintaining patency of the esophagus in cases of obstruction of the esophagus caused by an esophageal disease and to seal tracheoesophageal fistula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinically relevant device migration | Clinically relevant device migration is defined as stent migration requiring replacement of the stent due to degree of migration as well as clinical symptoms (i.e. an inability of the stent to perform its intended function). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unresectable esophageal malignancies, Benign strictures, Tracheoesophageal fistulas, Esophageal stents