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

Not Applicable

• Conditions: Benign Esophageal Stricture
• Interventions: Device: BD-Covered esophageal stent

• Registration Number: NCT03189927
• Lead Sponsor: Radboud University Medical Center

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 Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16
• Study Start: 2017-07-01
• Primary Completion: 2018-07-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	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)	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 Outcome Measures

Name	Time	Method
Esophageal pain, measured with VAS during follow-up after stent placement	6 months	Pain will be measured with the VAS during follow-up
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up	6 months	Recurrent dysphagia during follow-up