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

Cook Group

Status

Completed

Conditions

Esophageal Diseases

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT05182255

MDR-2054

Details and patient eligibility

About

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).

Full 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

Enrollment

127 patients

Sex

All

Volunteers

No Healthy Volunteers

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

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.