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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07780981
Status
Recruiting
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Conditions

  • Achalasia
  • Dysphagia
  • Eosinophilic Esophagitis (EoE)
  • Epidermolysis Bullosa (EB)
  • Esophageal Motility Disorders
  • Esophageal Stricture

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Jul 24, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Other: Left lateral position first, supine position second
  • Other: supine position first, Left lateral position second

Primary Outcome Measure

Diameter [ Time Frame: During procedure only (less than 10 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Charlotte R. Bloomberg Children's CenterBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Charlotte R. Bloomberg Children's Center· Baltimore, MD

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