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

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).

Study Overview

• Status: Recruiting
• Conditions: Esophageal Diseases
• Intervention / Treatment: Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially 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 Type: Observational
• Enrollment (Estimated): 313

Contacts and Locations

• Study Contact: Name: Line Melgaard Svendsen; Phone Number: +45 56868686; Email: linemelgaard.svendsen@cookmedical.com

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Recruiting
    • Klinikum Altenburg
  • Augsburg, Germany, 86156
    • Recruiting
    • Universitatsklinikum Augsburg
  • Düsseldorf, Germany, 40217
    • Completed
    • Evangelisches Krankenhaus Düsseldorf
• Spain
  • ESP
    • Salamanca, ESP, Spain, 370007
      • Completed
      • Hospital Universitario de Salamanca
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Completed
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Esophageal Stent Systems; Freedom from endoscopic re-intervention due to recurrence of dysphagia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Unresectable esophageal malignancies; Benign strictures; Tracheoesophageal fistulas; Esophageal stents
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases
• Other Study ID Numbers: MDR-2054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.