RecruitingNot ApplicableNCT06364553

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


Sponsor

Erasmus Medical Center

Enrollment

30 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of a self-expanding metal stent placed in the esophagus to relieve swallowing difficulties in patients with incurable esophageal or stomach-junction cancer that is causing a blockage. **You may be eligible if...** - You have difficulty swallowing (dysphagia) caused by an inoperable malignant obstruction or compression of the esophagus or esophageal-stomach junction - Your cancer cannot be cured and your life expectancy is less than 12 months - You are 18 or older **You may NOT be eligible if...** - Your obstruction is after a laryngectomy (throat removal surgery) - The stent placement site is less than 2 cm from the top of the esophagus - Your tumor is longer than 14 cm - You previously had a stent placed for the same condition - You have uncorrected blood-clotting problems - You have eosinophilic esophagitis or an esophageal movement disorder - You have a nickel-titanium (Nitinol) allergy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEsophageal self-expandable metal stent

The Leufen Esophageal aixstent ® (Leufen Medical GmbH) is indicated for the treatment of malignant esophageal strictures and postoperative stenosis. It is comprised of two components: an implantable metallic stent and the delivery system. After the procedure, the stent remains at the intended location, within the patient while the delivery system is removed.


Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT06364553


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