An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorUniversity Children's Hospital, Zurich

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Stenosis that cannot be treated endoscopically

Malignant esophageal strictures

Contraindications and limitations of the MD as described in the instructions for use

Trial design

Treatments tested in this trial

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

Treatment groups

40 Participants
are divided into 2 treatment groups