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

Esophageal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182255
• Other study ID #: MDR-2054
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Diseases

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