Clinical trial · Observational
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
NCT05182255CI-TRIAL-00085881completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Esophageal Stent Systems
- description
- Freedom from endoscopic re-intervention due to recurrence of dysphagia
- interventionNames
- Device: Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
Primary outcomes (1)
- measure
- Number of participants with clinically relevant device migration
- timeFrame
- 6 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.