BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study

Conditions
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Benign Esophageal Stricture

Intervention / Treatment
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* Device: BD-Covered esophageal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both genders Age ≥ 18 years Appropriate cultural level and understanding of the study Willingness to participate voluntarily in the study and give written informed consent Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy. Ability to undergo periodic endoscopic follow-up. Exclusion Criteria: Pregnancy or breastfeeding Simultaneous participation in another clinical study Life expectancy of less than 12 months Malignant esophageal stricture Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter Undergone an esophageal stent implantation before.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BD-Covered stent<br>Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae | Device: BD-Covered esophageal stent<br>* a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pain, measured with VAS during follow-up after stent placement | Pain will be measured with the VAS during follow-up | 6 months | 
| Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up | Recurrent dysphagia during follow-up | 6 months |