An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

Recruiting now · Not applicable

Conditions studied: Esophageal Stenosis, Esophageal Dilation

In brief

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.

Key facts

Study ID

NCT06675825

Run by

University Children's Hospital, Zurich

People needed

40

Starts

2025-01-01

Expected to finish

2026-12-01

Last updated by the study team

2024-12-11

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Stenosis that cannot be treated endoscopically
• Malignant esophageal strictures
• Contraindications and limitations of the MD as described in the instructions for use

Where it is running

• Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome, — Rome, Italy (enrolling)
• University Children's Hospital Zurich — Zurich, Canton of Zurich, Switzerland (enrolling)
• Universitäts-Kinderspital beider Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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