Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions

NCT07780981 | Recruiting FDA Device

• 1 other identifier: IRB00560539
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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; Eosinophilic Esophagitis (EoE)

Keywords

Pediatric; EndoFlip; Position; Lateral; supine; measurement

Outcome Measures

Primary Outcomes (5)

• Diameter

  Diameter of esophagus (mm)

  During procedure only (less than 10 minutes)

• Cross sectional area

  Esophageal cross sectional area measured in square millimeters (mm²)

  During procedure only (less than 10 minutes)

• Compliance

  esophageal compliance (mm3/mmHg)

  During procedure only (less than 10 minutes)

• distensibility index

  esophageal distensibility index(mm2/mmHg)

  During procedure only (less than 10 minutes)

• Pressure

  intraluminal esophageal pressure (mmHg)

  During procedure only (less than 10 minutes)

Secondary Outcomes (5)

• Differences in diameter

  During procedure only (less than 10 minutes)

• Differences in Cross sectional area

  During procedure only (less than 10 minutes)

• Differences in esophageal compliance (mm3/mmHg)

  During procedure only (less than 10 minutes)

• Differences in esophageal distensibility index(mm2/mmHg)

  During procedure only (less than 10 minutes)

• Differences in intraluminal esophageal pressure (mmHg)

  During procedure only (less than 10 minutes)

Study Arms (2)

Left lateral position first, supine position second

OTHER

Diagnostic Test: EndoFlip

supine position first, Left lateral position second

OTHER

Diagnostic Test: EndoFlip

Interventions

EndoFlip DIAGNOSTIC_TEST

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.

Left lateral position first, supine position second; supine position first, Left lateral position second

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Charlotte R. Bloomberg Children's Center

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Stenosis; Epidermolysis Bullosa; Esophageal Achalasia; Esophageal Motility Disorders; Eosinophilic Esophagitis; Deception

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Kenneth Ng, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Ng, DO

CONTACT

410-955-8769; kng13@jhmi.edu

Ningfei Li, MD

CONTACT

4109556070; nli56@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)