NCT06364553

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia. Study design: Single center prospective observational non-randomized clinical study. Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
DEVICE	Esophageal 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.

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-04-15
• Last updated: 2025-08-07

Locations

1 site across 1 country: Netherlands