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NOT YET RECRUITING
NCT07754695
NA

Measuring Normal Esophageal Flexibility in Children Using EndoFLIP

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Official title: Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-01

Completion Date

2028-09-30

Last Updated

2026-09-08

Healthy Volunteers

Yes

Interventions

DEVICE

Endoluminal Functional Lumen Imaging Probe (EndoFLIP)

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.