An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children (NCT06675825) | Clinical Trial Compass
RecruitingNot Applicable
An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children
Italy, Switzerland40 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range
0 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.