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An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

RecruitingNAAges 0 Years - 18 YearsAllUniversity Children's Hospital, Zurich
NCT06675825 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to find out if using the BougieCap device is a safe and effective way to stretch narrow areas in the esophagus (food pipe) in children. The main questions this study wants to answer are: * Does the BougieCap work well to treat narrow areas in the esophagus comparing with other methods to widen these narrow areas? * Is BougieCap easy to use and does it cause fewer problems or discomfort for children? Researchers will compare two groups: one using the BougieCap, and the other using traditional methods like balloon dilation, to see which one works better and is safer. Participants will: * Answer questions about their symptoms before treatment, 24 hours after, and 14 days later. * Complete these questions during regular hospital visits or over the phone for the final check-up. This study does not involve any extra risks or burdens for the participants.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age under 18 years of age * Indication for endoscopic esophageal dilation * Benign stenosis * Written Informed Consent signed by the subject and/or parent/legal representative (if applicable) Exclusion Criteria: * Stenosis that cannot be treated endoscopically * Malignant esophageal strictures * Contraindications and limitations of the MD as described in the instructions for use
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What it tests

  • BougieCap
  • Savary-Bougie (A) or balloon dilation (B)
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Where

3 sites
Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,
Rome, Italy
University Children's Hospital Zurich
Zurich, Switzerland
Universitäts-Kinderspital beider Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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