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

Radboud University Medical Center

Status: Unknown

Conditions: Benign Esophageal Stricture

Treatments: Device: BD-Covered esophageal stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03189927

NL.59222.091.16

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

BD-Covered stent

Experimental group

Description:

Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae

Treatment:

Device: BD-Covered esophageal stent