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Natural History of Eosinophilic Esophagitis

NCT03290482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2021-08-12

No results posted yet for this study

Summary

Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

Conditions

  • Eosinophilic Esophagitis

Interventions

DIAGNOSTIC_TEST

Barium Esophagram

Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.

DEVICE

EsophaCap

Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)

DIAGNOSTIC_TEST

Physical Examination and Questionnaires

Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey A Alexander, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2019-11-01
Completion
2020-03-25
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03290482 on ClinicalTrials.gov