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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-28

Study Completion Date

2023-12-08

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).

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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

Spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55\_Data\_Protection\_Notice\_ESP.pdf

Conditions

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Esophageal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Esophageal Stent Systems

Freedom from endoscopic re-intervention due to recurrence of dysphagia

Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered

Intervention Type DEVICE

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.

Interventions

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Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered

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.

Intervention Type DEVICE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No