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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05182255
Other study ID # MDR-2054
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 28, 2022
Est. completion date December 2024

Study information

Verified date April 2024
Source Cook Group Incorporated
Contact Line Melgaard Svendsen
Phone +45 56868686
Email linemelgaard.svendsen@cookmedical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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


Recruitment information / eligibility

Status Recruiting
Enrollment 313
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Germany Klinikum Altenburg Altenburg
Germany Universitatsklinikum Augsburg Augsburg
Germany Evangelisches Krankenhaus Düsseldorf Düsseldorf
Spain Hospital Universitario de Salamanca Salamanca ESP
United Kingdom University College London London

Sponsors (1)

Lead Sponsor Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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