Measuring Normal Esophageal Flexibility in Children Using EndoFLIP

NCT07754695 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 00933870
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will measure normal esophageal flexibility (distensibility) in children using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Children who are already undergoing anesthesia for clinically indicated colonoscopy with colonic motility catheter placement and who have no history or symptoms of esophageal disease will undergo a brief EndoFLIP measurement lasting approximately 3-5 minutes before their scheduled procedure. The information collected will help establish preliminary normal pediatric reference values for esophageal distensibility, which may improve the evaluation of children with esophageal disorders in the future.

Conditions

Normal Esophageal Distensibility

Outcome Measures

Primary Outcomes (5)

• Esophageal Distensibility

  Esophageal distensibility index measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.

  During the procedure (approximately 3-5 minutes)

• Esophageal Diameter

  Esophageal diameter measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.

  During the procedure (approximately 3-5 minutes)

• Esophageal Cross-sectional Area

  Esophageal cross-sectional area measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.

  During the procedure (approximately 3-5 minutes)

• Esophageal Compliance

  Esophageal compliance measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.

  During the procedure (approximately 3-5 minutes)

• Intraballoon Pressure

  Intraballoon pressure measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.

  During the procedure (approximately 3-5 minutes)

Study Arms (1)

Asymptomatic Children Undergoing EndoFLIP Assessment

Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia who have no history or symptoms of esophageal disease. Participants undergo a single 3-5 minute EndoFLIP assessment before the scheduled procedure to measure esophageal distensibility index, diameter, cross-sectional area, compliance, and pressure for development of preliminary normative pediatric reference values.

Device: Endoluminal Functional Lumen Imaging Probe (EndoFLIP)

Interventions

Endoluminal Functional Lumen Imaging Probe (EndoFLIP) DEVICE

The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared impedance planimetry device used to measure esophageal diameter, cross-sectional area, intraballoon pressure, distensibility index, and compliance. In this study, the EndoFLIP catheter is inserted orally during general anesthesia immediately before clinically indicated colonoscopy with colonic motility catheter placement. Measurements are obtained over approximately 3-5 minutes at standardized balloon fill volumes of 20-60 mL, after which the catheter is removed and the planned clinical procedure proceeds. The EndoFLIP assessment is performed solely for research purposes to establish preliminary normative pediatric esophageal biomechanical reference values.

Asymptomatic Children Undergoing EndoFLIP Assessment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement at Riley Hospital for Children who have no history or symptoms of esophageal disease and are eligible to undergo a brief EndoFLIP assessment during the same anesthetic.

You may qualify if:

• Age 5 to \<18 years
• Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
• No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
• No history of esophageal disease or esophageal surgery
• Parent/guardian consent and participant assent, when applicable

You may not qualify if:

• Known or suspected esophageal pathology
• Prior esophageal surgery or instrumentation
• Anatomic upper gastrointestinal abnormalities
• Contraindication to anesthesia or EndoFLIP catheter placement

Sponsors & Collaborators

• Indiana University: lead
• Medtronic: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Gastroenterologist

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08