Using a new device to treat narrow esophagus in children
A Novel Endoscopic Attachment Cap for Benign Esophageal Stricture Dilation in Children: a Randomized, Multicentric Pilot Study.
NA · University Children's Hospital, Zurich · NCT06675825
This study is testing a new device called BougieCap to see if it can safely help children with a narrow esophagus feel better compared to traditional treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich (other) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Rome and 2 other locations) |
| Trial ID | NCT06675825 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years with benign esophageal strictures requiring endoscopic dilation.
Not a fit: Patients with malignant esophageal strictures or those whose stenosis cannot be treated endoscopically will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for children with esophageal strictures.
How similar studies have performed: While there have been studies on esophageal dilation methods, the BougieCap device represents a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome and 2 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Stenosis, Esophageal Dilation, esophageal stricture, esophageal dilation, pediatric gastroenterology