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

Completed

• Conditions: Esophageal Diseases

• Registration Number: NCT05182255
• Lead Sponsor: Cook Research Incorporated

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 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

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-10
• Study Start: 2022-04-28
• Primary Completion: 2023-12-08
• Study Completion: 2023-12-08
• Status Verified: 2024-07
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically relevant device migration	6 months	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).

Trial Locations

Locations (5)

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany

Klinikum Altenburg; 🇩🇪 Altenburg, Germany

University College London; 🇬🇧 London, United Kingdom

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, ESP, Spain

Universitatsklinikum Augsburg; 🇩🇪 Augsburg, Germany