A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Incidence of treatment associated adverse events during follow-up (safety)
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
Time frame: 6 months
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Time frame: 1 day
Esophageal pain, measured with VAS during follow-up after stent placement
Pain will be measured with the VAS during follow-up
Time frame: 6 months
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Recurrent dysphagia during follow-up
Time frame: 6 months
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