Measuring Normal Esophageal Flexibility in Children Using EndoFLIP (NCT07754695) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Measuring Normal Esophageal Flexibility in Children Using EndoFLIP
100 participantsStarted 2026-08-01
Plain-language summary
This study will measure normal esophageal flexibility (distensibility) in children using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Children who are already undergoing anesthesia for clinically indicated colonoscopy with colonic motility catheter placement and who have no history or symptoms of esophageal disease will undergo a brief EndoFLIP measurement lasting approximately 3-5 minutes before their scheduled procedure. The information collected will help establish preliminary normal pediatric reference values for esophageal distensibility, which may improve the evaluation of children with esophageal disorders in the future.
Who can participate
Age range
5 Years – 17 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 5 to \<18 years
* Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
* No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
* No history of esophageal disease or esophageal surgery
* Parent/guardian consent and participant assent, when applicable
Exclusion Criteria:
* Known or suspected esophageal pathology
* Prior esophageal surgery or instrumentation
* Anatomic upper gastrointestinal abnormalities
* Contraindication to anesthesia or EndoFLIP catheter placement
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.
What they're measuring
1
Esophageal Distensibility
Timeframe: During the procedure (approximately 3-5 minutes)
2
Esophageal Diameter
Timeframe: During the procedure (approximately 3-5 minutes)
3
Esophageal Cross-sectional Area
Timeframe: During the procedure (approximately 3-5 minutes)
4
Esophageal Compliance
Timeframe: During the procedure (approximately 3-5 minutes)
5
Intraballoon Pressure
Timeframe: During the procedure (approximately 3-5 minutes)