Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06364553

Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

Led by Erasmus Medical Center · Updated on 2025-08-07

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

CONDITIONS

Official Title

Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients
  • Requiring treatment for dysphagia with an Ogilvie score of 2-4
  • Life expectancy of less than 12 months
  • Written informed consent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Stenosis after laryngectomy
  • Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter
  • Tumor length of more than 14 cm
  • Previous stent placement for the same condition
  • Coagulopathy not corrected prior to stent placement
  • Patients with eosinophilic esophagitis or an esophageal motility disorder
  • Allergy to nickel titanium (Nitinol)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015GD

Actively Recruiting

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Research Team

A

Annemijn D I Maan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study | DecenTrialz