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

N/A
Waitlist Available
Led By Margaret Marcon, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Summary

This trial tests if the CytospongeTM, a small sponge in a capsule, can safely and effectively collect tissue samples from the esophagus in children and teens with a specific condition. The goal is to see if it can replace traditional methods, which are more invasive. The sponge collects tissue as it is pulled back up after swallowing. The Cytosponge is a minimally invasive device developed to collect esophageal tissue samples.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following the endoscopy procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following the endoscopy procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared
Secondary study objectives
Histology comparison of supernant obtained from sponge and esophageal pinch biopses
Likert scale (10 point) evaluating patient and caregiver satisfaction
Questionairre evaluating Patient and caregiver satisfaction

Trial Design

1Treatment groups
Experimental Treatment
Group I: HistologyExperimental Treatment1 Intervention
Specimen samples from the tradition pinch esophageal biopsy and the supernatant sample obtained from the mesh sponge (Cytosponge TM) will each be fixed and stained. The eosinophil count per high power field for the mesh sponge sample and the traditional biopsy sample will be compared for each subject.

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Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,847 Total Patients Enrolled
Margaret Marcon, MDPrincipal InvestigatorThe Hospital for Sick Children
~9 spots leftby Sep 2025
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