Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 24 Jul 2026
- Expected to end
- 1 Jul 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- EndoFlip
- Record updated
- 24 August 2026
Who can take part
- Age
- 5 years to 21 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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 younger than 5 years of age or 22 years of age and older will be excluded
- 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 who cannot be safely positioned in both supine and left lateral decubitus positions due to medical or anatomical considerations 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 21 years old?
Where in United States
- Charlotte R. Bloomberg Children's CenterBaltimore, United StatesContact: Kenneth Ng, DOTaking people
About the trial
What the trial wants to find out
This is a prospective, single-center, crossover study comparing EndoFLIP measurements obtained in two patient positions, supine and left lateral decubitus, in pediatric and young adult patients. The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 and older that utilizes high-resolution impedance planimetry and volume-controlled distension to assess esophagogastric junction function. Currently, no standardized positioning protocol exists, and proceduralists perform EndoFLIP based on individual preference, either supine or left lateral decubitus. This variability may introduce measurement inconsistencies, particularly when comparing preoperative and postoperative assessments performed in different positions.
The 2 groups in the trial
- Left lateral position first, supine position secondOther group
Treatment: EndoFlip
- supine position first, Left lateral position secondOther group
Treatment: EndoFlip
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07780981, who can take part
- Record updated
- 24 August 2026