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An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

Study acronym: BOUGIE-PED
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Nov 2024 to Jan 2025
    • Primary and study completion dates: Nov 2026 to Dec 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06675825
Lead Sponsor University Children's Hospital, Zurich
Conditions
(from sponsor)		 Esophageal Stenosis, Esophageal Dilation
Related terms Esophageal Stenosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov