Clinical trial NCT05182255: Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
Official title: Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Diseases
Keywords: Unresectable esophageal malignancies
Benign strictures
Tracheoesophageal fistulas
Esophageal stents
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent stent placement with a study device between Jan 1,2018 thru Dec 31, 2020

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with clinically relevant device migration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: Klinikum Altenburg
city: Augsburg
country: Germany
facility: Universitatsklinikum Augsburg
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: ESP
city: London
country: United Kingdom
facility: University College London
Study officials:
References: