Using a new device to treat narrow esophagus in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of the BougieCap device for dilating benign esophageal strictures in children. Participants will be divided into two groups: one receiving treatment with the BougieCap and the other using traditional methods like balloon dilation. The study will assess symptom improvement and ease of use for the BougieCap compared to standard techniques. Data will be collected through questionnaires before treatment and at follow-up intervals to monitor outcomes. The study is designed to minimize risks and burdens for participants.

Why it matters

Who can join: the full rules

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

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.