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

NCT05182255 | Completed

• 1 other identifier: MDR-2054
• Study Type: observational
• Target: 127
• Locations: 3 countries
• Sites: 5

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).

Conditions

Esophageal Diseases

Keywords

Unresectable esophageal malignancies; Benign strictures; Tracheoesophageal fistulas; Esophageal stents

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Esophageal Stent Systems

Freedom from endoscopic re-intervention due to recurrence of dysphagia

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

Interventions

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

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.

Esophageal Stent Systems

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• : 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

You may not qualify if:

• : 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.

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (5)

Klinikum Altenburg

Altenburg, 04600, Germany

Location

Universitatsklinikum Augsburg

Augsburg, 86156, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Hospital Universitario de Salamanca

Salamanca, ESP, 370007, Spain

Location

University College London

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Diseases; Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Esophageal Fistula; Digestive System Fistula; Respiratory Tract Fistula; Respiratory Tract Diseases; Tracheal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 10, 2022
• Study Start: April 28, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: February 12, 2025

Record last verified: 2024-07

Locations

GB (1); ES (1); DE (3)