Epidermolysis Bullosa Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 21
Healthy Volunteers: f
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• 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.

Locations
United States
Maryland
Charlotte R. Bloomberg Children's Center
RECRUITING
Baltimore
Contact Information
Primary
Kenneth Ng, DO
kng13@jhmi.edu
410-955-8769
Backup
Ningfei Li, MD
nli56@jh.edu
4109556070
Time Frame
Start Date: 2026-07-24
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 25
Treatments
Other: Left lateral position first, supine position second
Other: supine position first, Left lateral position second
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov