Status:
UNKNOWN
Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoE
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
The aim of the present study is determining the accuracy, safety and tolerance of the CytospongeTM (expandable sponge within a gelatin capsule attached to a string) relative to traditional upper endos...
Detailed Description
This is a cross-sectional study in pediatric subjects comparing histologic findings on esophageal biopsies obtained during upper GI endoscopies to histologic findings on tissue samples obtained throug...
Eligibility Criteria
Inclusion
- Previous histologic diagnosis of eosinophilic esophagitis (symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field on esophageal biopsy and after a comprehensive assessment of non-EoE disorders that could cause or potentially contribute to esophageal eosinophilia).1
- Capable of swallowing a capsule 3 cm in length (trial with 3 cm jelly candy).
- 10 to 18 years of age.
- Male or female.
- Able to give assent or consent.
- Scheduled for an upper gastrointestinal endoscopy with biopsies on the same day to assess response to therapy and make decisions regarding further management.
Exclusion
- Unable to swallow the capsule.
- Unable to give assent or consent.
- History of esophageal stricture on either upper gastrointestinal barium study or previous upper gastrointestinal endoscopy of food impaction that required removal.
- History of portal hypertension or esophageal varices.
- History of solid organ transplantation.
- Known bleeding diathesis.
- On anticoagulation therapy.
- Known platelet count less than normal for age.
- Pregnancy.
- Need for intubation during endoscopy.
- History of previous esophageal surgery.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05342168
Start Date
April 1 2022
End Date
September 1 2023
Last Update
April 22 2022
Active Locations (1)
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1
Sickkids
Toronto, Ontario, Canada, M5G 1X8