NCT05182255

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Esophageal Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2022-01-10
• Last updated: 2025-02-12

Locations

5 sites across 3 countries: Germany, Spain, United Kingdom