Recruiting

EndoFLIP Measurements

Sponsor:

Johns Hopkins University

Code:

NCT07780981

Conditions

Dysphagia

Esophageal Stricture

Epidermolysis Bullosa (EB)

Achalasia

Esophageal Motility Disorders

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

EndoFlip

Study Details

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.

Conditions

Dysphagia

Esophageal Stricture

Epidermolysis Bullosa (EB)

Achalasia

Esophageal Motility Disorders

Study ID

NCT07780981

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Left lateral position first, supine position second

other: supine position first, Left lateral position second

Interventions

EndoFlip

The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 years and older and it utilizes high-resolution impedance planimetry and volume-controlled distension to evaluate the GI lumen.

Primary outcome measure

  • Diameter [ Time Frame: During procedure only (less than 10 minutes) ]
  • Cross sectional area [ Time Frame: During procedure only (less than 10 minutes) ]
  • Compliance [ Time Frame: During procedure only (less than 10 minutes) ]
  • distensibility index [ Time Frame: During procedure only (less than 10 minutes) ]
  • Pressure [ Time Frame: During procedure only (less than 10 minutes) ]

Central Contacts and Locations

Central contacts

Kenneth Ng, DO

410-955-8769kng13@jhmi.edu

Ningfei Li, MD

4109556070nli56@jh.edu

Locations

Charlotte R. Bloomberg Children's Center

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Pediatric
  • EndoFlip
  • Position
  • Lateral
  • supine
  • measurement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.