Could lying flat vs. on your side change esophageal test results?
NCT ID NCT07780981
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This study tests whether the position a child lies in during an EndoFLIP procedure—flat on their back (supine) or on their left side—changes the measurements of esophageal function. EndoFLIP is an FDA-approved device that measures how well the esophagus opens and moves food. The trial enrolls children and young adults (ages 5–21) already scheduled for this procedure at Johns Hopkins Children's Center. Each participant will have measurements taken in both positions to see if they differ, which could help standardize the test in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EndoFLIP (Endoluminal Functional Lumen Imaging Probe) — a diagnostic device that measures esophageal function during a procedure.
- What this could lead to
- If positioning affects measurements, standardizing the procedure could improve accuracy of esophageal assessments in children.
- What could go wrong
- This is a small, early study (25 participants) focused on measurement variability, not treatment outcomes. Results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * must be between 5 years and 21 years of age at the time of the procedure, which is within the FDA-approved age range for EndoFLIP use. * participants must be scheduled to undergo a clinically indicated EndoFLIP procedure at Johns Hopkins Children's Center. * participants must have a parent or legal guardian who is able to provide written informed consent in English, or with the assistance of translation services for non-English speakers. * participants who are of appropriate age and developmental capacity must be able to provide assent for study participation. * participants must be candidates for general anesthesia as determined by the anesthesia team. Exclusion Criteria: * patients younger than 5 years of age or 22 years of age and older will be excluded. * patients who have contraindications to EndoFLIP will be excluded, including situations where upper endoscopy is generally contraindicated such as known or suspected gastrointestinal perforation, hemodynamic instability, severe coagulopathy, or inability to safely undergo general anesthesia. * patients who cannot be safely positioned in both supine and left lateral decubitus positions due to medical or anatomical considerations will be excluded. * pregnant patients will be excluded. Pregnancy status will be determined by patient or guardian report and, when clinically indicated, by urine or serum pregnancy testing per institutional protocols for patients of childbearing potential. * patients whose parent or legal guardian declines to provide informed consent or patients who decline to provide assent when age-appropriate will be excluded. * patients for whom the proceduralist or anesthesia team determines that participation in the research protocol would pose additional risk beyond routine clinical care will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Charlotte R. Bloomberg Children's Center
RECRUITINGBaltimore, Maryland, 21287, United States
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