NCT07780981 Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
| NCT ID | NCT07780981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-07-24 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-07-24 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Kenneth Ng, DO
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07780981 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07780981 currently recruiting?
Yes, NCT07780981 is actively recruiting participants. Contact the research team at kng13@jhmi.edu for enrollment information.
Where is the NCT07780981 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07780981 clinical trial?
NCT07780981 is sponsored by Johns Hopkins University. The principal investigator is Kenneth Ng, DO at Johns Hopkins University. The trial plans to enroll 25 participants.