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Pilot Study of Esocheck in Eosinophilic Esophagitis

NCT04311970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-09-22

No results posted yet for this study

Summary

Eosinophilic esophagitis (EoE) is a prevalent chronic inflammatory condition of the esophagus characterized by esophageal eosinophilia that can lead to inflammation and stricture formation. To assess remission, esophagogastroduodenoscopies (EGD) with biopsies are performed. This can lead to multiple EGDs, which are invasive and costly procedures. EsoCheck is a promising noninvasive device. It is an encapsulated balloon that can be easily swallowed and collect cells from the distal esophagus. The primary aim of this study is to determine the feasibility and safety of EsoCheck compared with standard endoscopy and biopsies in the assessment of EoE. This will be a prospective cross-sectional study of adult patients (greater than or equal to 22 years of age) at the University of Pennsylvania with a diagnosis of EoE scheduled for a clinically indicated upper endoscopy.

Conditions

  • Eosinophilic Esophagitis
  • Diagnoses Disease

Interventions

DEVICE

EsoCheck

All patients with known diagnosis of EoE will be administered the EsoCheck device prior to standard of care endoscopy

Sponsors & Collaborators

Principal Investigators

  • Gary W Falk, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2021-08-23
Completion
2021-08-23
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 NCT04311970 on ClinicalTrials.gov