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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following the endoscopy procedure

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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