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.

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.