Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new esophageal self-expandable metal stent (SEMS) designed to relieve malignant dysphagia, which is difficulty swallowing caused by cancer-related narrowing of the esophagus. This prospective observational study will include about 20 patients and compare the results to historical data from over 1000 patients who previously received esophageal stents. The study is conducted at a single center and is non-randomized. Participants will receive the Leufen Esophageal aixstent®, a device made of a metallic stent and a delivery system. The stent is implanted to keep the esophagus open and relieve swallowing difficulties caused by malignant strictures or obstructions. After placement, the delivery system is removed while the stent remains in place. This study observes patients following the procedure without comparing to a placebo or alternative treatments. During the study, participants will be monitored for up to six months for various complications such as perforation, bleeding, fistula formation, gastroesophageal reflux, and stent migration. The success of the stent placement will also be evaluated immediately after the procedure. Researchers will assess clinical outcomes, pain related to the stent, recurrence of swallowing problems, and overall survival during the follow-up period. The total participation time may last up to six months after stent placement.
CONDITIONS
Brief Title
Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with swallowing difficulty due to non-curable malignant obstruction of the esophagus or esophagogastric junction
- Patients requiring treatment for dysphagia with an Ogilvie score of 2 to 41
- Life expectancy less than 12 months
- Written informed consent provided
- Age 18 years or older
You will not qualify if you...
- Stenosis after laryngectomy
- Upper edge of the stent less than 2 cm from the upper esophageal sphincter
- Tumor length more than 14 cm
- Previous stent placement for the same condition
- Uncorrected coagulopathy before stent placement
- Eosinophilic esophagitis or esophageal motility disorders
- Allergy to nickel titanium (Nitinol)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day (stent placement)
Participants undergo placement of the esophageal self-expandable metal stent to treat malignant strictures.
1 visit (in-person)
Duration - 6 months
Participants are monitored for safety and efficacy outcomes including complications and symptom relief after stent placement.
Regular visits during the 6 months following stent placement
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
A
Annemijn D I Maan
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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