Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa for Eosinophilic Esophagitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sickkids, Toronto, Canada
Eosinophilic Esophagitis+1 More
Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa - DiagnosticTest
Eligibility
< 65
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a CytospongeTM is a more accurate, safe and tolerated alternative to upper endoscopy and esophageal biopsies for diagnosing Eosinophilic Esophagitis in children and adolescents. The CytospongeTM is a device that is swallowed in order to obtain a sample of the esophageal mucosa. This device has been approved by the FDA for a different condition, and is now being used in a clinical trial to treat Eosinophilic Esophagitis. There is no placebo group in this trial.

Eligible Conditions

  • Eosinophilic Esophagitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Eosinophilic Esophagitis

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: immediately following the endoscopy procedure

1 week
Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared
immediately following endoscopy procedure
Questionairre evaluating Patient and caregiver satisfaction
immediately following the endoscopy procedure
Likert scale (10 point) evaluating patient and caregiver satisfaction
one week
Histology comparison of supernant obtained from sponge and esophageal pinch biopses

Trial Safety

Safety Progress

1 of 3

Other trials for Eosinophilic Esophagitis

Trial Design

1 Treatment Group

Histology
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa · No Placebo Group · N/A

Histology
DiagnosticTest
Experimental Group · 1 Intervention: Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately following the endoscopy procedure
Closest Location: Sickkids · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2019First Recorded Clinical Trial
1 TrialsResearching Eosinophilic Esophagitis
3 CompletedClinical Trials

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
636 Previous Clinical Trials
6,815,944 Total Patients Enrolled
Margaret Marcon, MDPrincipal InvestigatorThe Hospital for Sick Children

Eligibility Criteria

Age < 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to swallow a capsule 3 cm in length.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References