Clinical Trial

An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

Study acronym: BOUGIE-PED
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-04.
Trial Details
NCT Number NCT06675825
Lead Sponsor University Children's Hospital, Zurich
Conditions Esophageal Stenosis, Esophageal Dilation
Enrollment 40 participants
Start Date 2025-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-11