BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 15
- Primary Endpoint
- 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
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Time Frame: 1 day
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Incidence of treatment associated adverse events during follow-up (safety)
Time Frame: 6 months
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.
Secondary Outcomes
- Esophageal pain, measured with VAS during follow-up after stent placement(6 months)
- Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up(6 months)