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Trial Title:
Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study
NCT ID:
NCT06364553
Condition:
Oesophageal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Esophageal self-expandable metal stent
Description:
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.
Arm group label:
Esophageal self-expandable metal stent
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 (Ogilvie score of 2-41);
- Life expectancy of less than 12 months;
- Written informed consent;
- Age ≥ 18 years.
Exclusion Criteria:
- 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;
- Nickel titanium (Nitinol) allergy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364553
