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Measuring Normal Esophageal Flexibility in Children Using EndoFLIP (EndoFLIP)

2. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Esophageal Distensibility
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University

Samarbejdspartnere

Medtronic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2028

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

31. juli 2026

Først indsendt, der opfyldte QC-kriterier

4. august 2026

Først opslået (Faktiske)

10. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 28226

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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