NCT05342168

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

Comparison of Histological Results Obtained From a Mesh Sponge (CytospongeTM) and Traditional Esophageal Mucosal Biopsies in Children and Adolescents With Eosinophilic Esophagitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa	A gelatin capsule containing the collapsed mesh sponge is swallowed with an attached string fixed to the cheek. After 8 minutes the gelatin capsule will have dissolved and the expanded soft mesh sponge can be with drawn sampling the surface of the esophagus on the way out. The sponge then will be spun and the supernant fixed, processed and stained.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2022-04-22
• Last updated: 2022-04-22

Locations

1 site across 1 country: Canada