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Measuring Normal Esophageal Flexibility in Children Using EndoFLIP (EndoFLIP)

2 september 2026 bijgewerkt door: Brett J. Hoskins, Indiana University

Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared device that measures the size, pressure, and flexibility (distensibility) of the esophagus. In adults, EndoFLIP measurements are routinely used to evaluate esophageal motility disorders such as achalasia. However, normal reference values for children have not been established, and pediatric interpretation currently relies largely on adult data.

The purpose of this prospective, single-center observational study is to generate preliminary normative pediatric EndoFLIP measurements. One hundred children between 5 and younger than 18 years of age who are undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia will be enrolled. Eligible participants must have no history of esophageal disease or surgery and no symptoms suggestive of upper gastrointestinal disease.

Immediately before the scheduled colonoscopy and motility catheter placement, an EndoFLIP catheter will be inserted through the mouth and positioned across the lower esophageal sphincter. Measurements of esophageal diameter, cross-sectional area, pressure, compliance, and distensibility index will be obtained at standardized balloon fill volumes (20-60 mL). The EndoFLIP assessment requires approximately 3-5 minutes and does not require an upper endoscopy or any additional anesthesia. After the measurements are completed, the catheter is removed and the planned clinical procedure proceeds as scheduled. No additional study visits or follow-up are required.

The primary objective is to establish preliminary normative pediatric values for esophageal distensibility and related biomechanical parameters. Secondary analyses will evaluate associations between EndoFLIP measurements and participant age, height, weight, and body mass index. These data are intended to improve interpretation of pediatric EndoFLIP studies and support future research and clinical care for children with esophageal disorders.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Esophageal Distensibility
Tijdsspanne: During the procedure (approximately 3-5 minutes)
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
Tijdsspanne: During the procedure (approximately 3-5 minutes)
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
Tijdsspanne: During the procedure (approximately 3-5 minutes)
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
Tijdsspanne: During the procedure (approximately 3-5 minutes)
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
Tijdsspanne: During the procedure (approximately 3-5 minutes)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Indiana University

Medewerkers

Medtronic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 september 2028

Studie voltooiing (Geschat)

30 september 2028

Studieregistratiedata

Eerst ingediend

31 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 28226

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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