Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children

Study on Esophageal Measurements in Children Using Device for Research Study

Primary Investigator
B
Brett Hoskins

Primary Investigator

Enrolling By Invitation
5 years - 17 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

Endoluminal functional lumen imaging probe (EndoFLIP) is a minimally invasive, novel device that aids in the diagnosis of esophageal disorders. EndoFLIP is increasingly utilized for assessing esophageal biomechanics, yet normative data for children are lacking. Due to developmental differences in compliance and luminal size, adult reference values are not generalizable to pediatrics. This study aims to generate normative pediatric EndoFLIP values by performing brief esophageal measurements in children with no history of esophageal disease or symptoms who are already under anesthesia for colonic motility testing. This timing is optimal, as the anesthetic regimen used for colonic manometry catheter placement avoid s medications that typically alter esophageal parameters or motility findings.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Current patients of our pediatric GI division, scheduled for a colonoscopy with motility catheter placement in the Main OR, will be approached for participation. Families will be contacted in advance whenever possible, either during a clinic visit or via telephone prior to the procedure day, to allow adequate time for decision-making. Consent/assent will then be confirmed on the day of the procedure in the Main OR private room or obtained the day of the procedure only if prior contact was not practicable. Once signed, the EndoFLIP measurements will be obtained intraoperatively for 3-5 minutes prior to the colonic motility catheter placement.

Detailed description of study

This is a prospective, single-center, observational study involving 100 pediatric patients undergoing colonoscopy with colonic motility catheter placement. EndoFLIP measurements will be performed intraoperatively for 3–5 minutes while the patient is under anesthesia. This timing is optimal, as the anesthetic regimen used for colonic manometry catheter placement avoid medications that typically alter esophageal parameters or motility findings. A diagram depicting the study is included below.

Although EndoFLIP is not yet formally considered standard of care in pediatrics, it is FDA-cleared for esophageal use and has become widely adopted in adult practice. Over the past five years, EndoFLIP use in children has expanded rapidly, and it is now performed routinely at nearly all major children’s hospitals—most often in the evaluation of dysphagia. In this study, the device is applied briefly during an already indicated procedure, thereby minimizing incremental risk while allowing collection of normative pediatric data.

EndoFLIP measurements will be obtained during anesthesia, prior to colonic motility catheter placement. The EndoFLIP catheter is inserted orally and positioned across the lower esophageal sphincter for a brief measurement (3–5 minutes). During this time, balloon volumes (20–60 mL) are selected to provide graded assessments of distensibility. Multiple volumes allow construction of pressure–diameter/compliance curves and evaluation across physiologic ranges. These volumes align with published adult protocols. No upper endoscopy will be performed. The catheter is removed following measurement. All procedures are conducted under general anesthesia already indicated for the scheduled motility evaluation.

Participants are already undergoing general anesthesia and endoscopic procedures as part of their scheduled care. Esophageal balloon measurements represent an experience reasonably equivalent to the medical and procedural context the child is already in. EndoFLIP measurements add only a brief 3-5 minute procedure under anesthesia. The balloon is pressure-limited by the system, reducing risk.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lower gastrointestinal symptoms, Riley
  • Age: 5 years - 17 years
  • Gender: All

Inclusion Criteria
•    Age 5–•    Scheduled colonoscopy with motility catheter placement under anesthesia for evaluation of lower gastrointestinal symptoms (e.g., constipation)
•    No upper gastrointestinal symptoms (e.g., dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia) 
•    No history of esophageal disease or esophageal surgery
•    Consent/assent provided

Exclusion Criteria
•    Known or suspect esophageal pathology
•    Prior esophageal surgery or surgical instrumentation
•    Anatomic upper gastrointestinal abnormalities
•    Intubation or airway contraindications

The purpose of this study is to investigate esophageal measurements in children using a device called EndoFLIP. This study is looking at how stretchy the esophagus is in children who do not have esophageal problems. The esophagus is a tube that carries food from the mouth to the stomach. EndoFLIP is a tool that helps doctors see how the esophagus moves and stretches. It is usually used for adults, but this study wants to find out what is normal for kids.

In this study, children who are already having a medical procedure will have EndoFLIP measurements taken while they are asleep. The EndoFLIP device is put into the mouth and goes to the lower part of the esophagus. It uses a balloon to gently measure how the esophagus stretches for a few minutes. This does not add much time to the procedure and is safe because the children are under anesthesia. The information collected will help doctors understand more about children's esophagus.

  • Who can participate: Children aged 5 and older who are scheduled for a colonoscopy with a motility catheter placement under anesthesia can participate. They must not have any upper gastrointestinal symptoms or history of esophageal disease. Consent or assent must be provided.
  • Study details: Participants will have a brief EndoFLIP measurement during their scheduled procedure while under anesthesia. The EndoFLIP device is inserted orally and measures the esophagus using a balloon for 3-5 minutes. This is done safely under anesthesia and does not require additional endoscopy.
Updated on 07 Aug 2026. Study ID: 28226
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only