A Novel Endoscopic Attachment Cap for Benign Esophageal Stricture Dilation in Children: a Randomized, Multicentric Pilot Study.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,
RECRUITING
Rome
Switzerland
Universitäts-Kinderspital beider Basel
RECRUITING
Basel
University Children's Hospital Zurich
RECRUITING
Zurich
Time Frame
Start Date: 2025-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: Study Group 1: BougieCap
Patients randomized into this group will undergo the dilation using the BougieCap.
Active_comparator: Study Group 2: Standard treatment
Patients randomized to the standard treatment arm will be provided one of the two standard dilation techniques, Savary- Bougie dilation or balloon dilation. This procedure could take place under endoscopic or radiological control.
Related Therapeutic Areas
Sponsors
Leads: University Children's Hospital, Zurich

This content was sourced from clinicaltrials.gov

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