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

NCT03305653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-07-06

Study results available
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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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DEVICE

Esophageal String Test (EST)

The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.

Sponsors & Collaborators

Principal Investigators

  • Calies Menard-Katcher, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-03-01
Completion
2019-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305653 on ClinicalTrials.gov