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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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).

- 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 Criteria:

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05342168
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Hospital for Sick Children
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Margaret Marcon, MD
Principal Investigator Affiliation	The Hospital for Sick Children
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Histology

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sickkids, Toronto, Ontario, Canada

Status

Recruiting

Address

Sickkids

Toronto, Ontario, M5G 1X8

Site Contact

Kristen Bortolin, MD

kristen.bortolin@sickkids.ca

4168137735

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