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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

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.

Eligible Conditions

Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following endoscopy procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following endoscopy procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following endoscopy procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared

Secondary outcome measures

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

684 Previous Clinical Trials

6,944,966 Total Patients Enrolled

Margaret Marcon, MDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have enrolled in this research endeavor?

"Affirmative. Information posted on clinicaltrials.gov reveals that this study is actively recruiting participants, with the trial having been initiated back in April 1st 2022 and updated as recently as April 18th of the same year. The investigators intend to enrol 30 individuals at a single medical centre."

Answered by AI

Is enrollment for this research endeavor still available to volunteers?

"Affirmative. Clinicaltrials.gov conveys that this trail, first launched on April 1st 2022 and recently updated on the 18th of same month is currently recruiting participants. The research requires 30 people across a single site."

Answered by AI