Comparison of Histology From a Mesh Sponge & Traditional Esophageal

Status Recruiting

Clinical Trial 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 endoscopy and esophageal biopsies in older children and adolescents with a diagnosis of Eosinophilic Esophagitis (EoE) to follow up on treatment changes. The findings from this study could help determine whether the CytospongeTM is a more cost-effective alternative to traditional upper endoscopy for histologic follow-up in children and adolescents with EoE.

Clinical Trial 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 through the use of the CytospongeTM in a group of paediatric patients with a diagnosis of EoE. Subjects will swallow the Cytosponge capsule (attached to a string) several hours prior to their scheduled endoscopy for treatment assessment. An esophageal sample will be obtained by withdrawing the expanded sponge thru the esophagus. This will be sent to pathology and fixed and stained. The subject will also undergo routine upper endoscopy under conscious sedation and follow up biopsies obtained as per routine standard of care to assess current treatment for EoE. There will be a blinded comparison between the biopsies and the Cytosponge sample by two pediatric pathologist with experience with EoE. Subjects and their caregivers will also be surveyed on their experience using the Cytosponge compared to having endoscopy. This study has been performed in adults with Eosinophilic Esophagitis and found that the samples obtained with the Cytosponge was equivalent to the endoscopically obtained biopspes with out having to use endoscopy. Adult subjects also preferred the Sponge over having an endoscopy. The Cytosponge was shown to be safe and effected. Even larger adult trials in screening for esophageal cancer have shown the Cytosponge is safe and effective at sampling the esophagus. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05342168
Study type	Interventional
Source	The Hospital for Sick Children
Contact	Kristen Bortolin, MD
Phone	4168137735
Email	kristen.bortolin@sickkids.ca
Status	Recruiting
Phase	N/A
Start date	April 1, 2022
Completion date	September 1, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms