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Cytosponge Protocol IRB 11-006429

NCT01585103 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-06-13

Study results available
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Summary

This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.

Conditions

  • Eosinophilic Esophagitis

Interventions

DEVICE

Cytosponge

An ingestible gelatin capsule containing a compressed mesh attached to a string. The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released. The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Alexander, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-06-07
Completion
2016-06-07
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 NCT01585103 on ClinicalTrials.gov