Impact of Patient Position on EndoFLIP Measurements in Kids and Young Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center crossover study enrolls children and young adults aged 5 to 21 undergoing EndoFLIP at Johns Hopkins. Each participant will have measurements taken in both the supine and left lateral decubitus positions to determine how position affects EndoFLIP results. The trial uses a standardized EndoFLIP protocol and compares the two positions to reduce variability in esophagogastric junction assessment. The aim is to improve consistency for preoperative and postoperative evaluations in pediatric and young adult patients. No treatment beyond the EndoFLIP procedure itself is involved.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charlotte R. Bloomberg Children's Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Kenneth Ng, DO — Johns Hopkins University
• Study coordinator: Kenneth Ng, DO
• Email: kng13@jhmi.edu
• Phone: 410-955-8769

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Speedboat UltraSlim™ for POEM in adults with achalasia and other esophageal motility disorders.

  This registry will see if using the Speedboat UltraSlim™ device for POEM is safe and effective for adults with achalasia or other esophageal motility disorders.

  Recruiting Baylor College of Medicine · Houston, Texas · NCT07496840

• How surgery for obstructive sleep apnea affects swallowing and oral function

  This study compares swallowing and oral function before and after surgical treatment for OSA versus non-surgical care in adults with moderate-to-severe OSA.

  Recruiting National Sun Yat-sen University · Kaohsiung City · NCT07880067

• Full-thickness vs progressive myotomy in POEM for achalasia

  This trial tests whether a full-thickness myotomy during POEM works better than a partial, progressive approach for people with achalasia, to see which method better relieves symptoms with fewer side effects.

  Recruiting at 2 sites Phase 2 Cairo University · Cairo and 1 other locations · NCT07875686

• Energy-F703EB Cream for Epidermolysis Bullosa: a skin cream test in adults

  This phase 2 study tests ENERGI-F703EB Cream versus a matching vehicle to see if it is safe and helps small EB skin lesions in adults.

  Recruiting Phase 2 Energenesis Biomedical Co., Ltd. · Tainan · NCT07858422

• POEM vs Heller myotomy with Dor fundoplication for achalasia

  This trial tests POEM against laparoscopic Heller myotomy with Dor fundoplication to see which procedure better helps adults with achalasia.

  Recruiting Minia University · Minya, Minya Governorate · NCT07814027

• taVNS added to oral motor training for babies with severe swallowing trouble

  This trial tests whether pairing a noninvasive taVNS treatment with oral sensorimotor training helps infants in NICUs swallow better and feed more safely.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07802301

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.