25 Participants NeededMy employer runs this trial

EndoFLIP for Esophageal Motility Disorder

KN
NL
Overseen ByNingfei Li, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KN

Kenneth Ng, DO

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for children and young adults (age 5 and up) who have swallowing or esophageal problems, such as achalasia, strictures, or eosinophilic esophagitis. Participants must be able to undergo an EndoFLIP procedure.

Inclusion Criteria

Participants must have a parent or legal guardian able to provide written informed consent in English or with translation services for non-English speakers
I am scheduled for an EndoFLIP procedure at Johns Hopkins Children's Center.
I am able to safely undergo general anesthesia.
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Exclusion Criteria

I do not have any conditions that make EndoFLIP unsafe for me.
Patients whose parent or legal guardian declines to provide informed consent or patients who decline to provide assent when age-appropriate
Patients for whom the proceduralist or anesthesia team determines participation would pose additional risk beyond routine clinical care
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • EndoFLIP

Trial Overview

The study compares how body position—lying on the back (supine) versus lying on the left side—affects measurements taken by the EndoFLIP device during a single visit. Each participant will try both positions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: supine position first, Left lateral position secondExperimental Treatment1 Intervention
Group II: Left lateral position first, supine position secondExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+