N/A N=21 Basic Science

Use of Esophageal String Test to Understand Symptoms, Inflammation, and Function in Eosinophilic Esophagitis

Eosinophilic Esophagitis

Bottom Line

View on ClinicalTrials.gov: NCT03305653 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Measurement of Eosinophilic Degranulating Protein Concentration — 456.5 ng/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Esophageal String Test (EST) (Device)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Measurement of Eosinophilic Degranulating Protein Concentration	456.5	—

Summary

Presently, the only method available to monitor disease activity in Eosinophilic Esophagitis (EoE) is endoscopy with pathological review of biopsies. The overall goal of this study is to determine the ability of the Esophageal String Test (EST), a minimally invasive capsule based technology, to measure disease activity in children with EoE. Additionally, to determine esophageal distensibility in children presenting with EoE by using the EndoFLIP (functional luminal imaging probe) device during endoscopic procedures.

Eligibility Criteria

Inclusion Criteria

Provide signed and dated informed consent form.
Willing to comply with all study procedures and be available for the duration of the study.
Male or female, aged 7 to 18 years old, inclusive
Undergoing upper Endoscopy with biopsy for clinical care at CHCO or CHOP
Current or historical diagnosis of EoE, or suspected of having EoE

Exclusion Criteria

Known connective tissue disease, other eosinophilic disorders
Past history of caustic injestion, esophageal surgery or other esophageal injury
Known inflammatory bowel disease or esophageal motility disease (achalasia)
Unwilling or unable to swallow the EST
Oral or intravenous steroids in the preceding 60 days (not including swallowed topical fluticasone, budesonide, etc)
Pregnancy
Participation in a clinical study that may interfere with participation in this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03305653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.