Cytosponge for EoE

KB
MM
Overseen ByMargaret Marcon, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to examine the esophagus in children and teens with eosinophilic esophagitis (EoE), a condition that causes painful swelling in the esophagus. Instead of the usual scope and biopsy, the trial uses a small, swallowable sponge capsule called the CytospongeTM. The researchers aim to determine if this new method is accurate, safe, and easier for follow-ups. Children and teens diagnosed with EoE, who can swallow a small capsule and are already scheduled for an endoscopy, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could simplify and improve future EoE diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation therapy, you may not be eligible to participate.

What prior data suggests that the CytospongeTM is safe for use in older children and adolescents with EoE?

Research shows that the Cytosponge, a small sponge inside a capsule, is generally safe and easy to use for collecting cells from the esophagus. Studies have found that healthcare settings can safely use it, offering a less invasive option compared to traditional methods like endoscopy. Although a small chance exists for minor issues like tiny tears in the esophagus, these are rare. Most people undergo the procedure without major problems. Overall, the Cytosponge provides a safe way to sample esophageal cells.12345

Why are researchers excited about this trial?

Researchers are excited about using the Cytosponge TM for sampling the esophageal mucosa in children and adolescents with eosinophilic esophagitis (EoE) because it offers a non-invasive and potentially more comfortable alternative to traditional biopsies. Unlike standard endoscopic biopsies that require sedation and can be quite uncomfortable, the Cytosponge TM is a small, expandable sponge that is swallowed and then retrieved, offering a simpler and less distressing experience. This method could make it easier to monitor EoE by providing a more convenient way to collect tissue samples, potentially leading to more frequent monitoring and better disease management.

What evidence suggests that the CytospongeTM is effective for Eosinophilic Esophagitis?

Research shows that the Cytosponge, a new tool for collecting cells from the esophagus, could help diagnose conditions like Eosinophilic Esophagitis (EoE). Studies have found that the Cytosponge successfully collects samples from the esophagus in over 90% of cases in some trials. It offers a simpler and less invasive option compared to traditional methods like endoscopy. In certain instances, the Cytosponge has collected samples in 75% of patients. Although still under study, these results suggest it might effectively monitor EoE in children and teens. Participants in this trial will have samples collected using the Cytosponge, and researchers will compare its effectiveness to traditional biopsy techniques.16789

Who Is on the Research Team?

MM

Margaret Marcon, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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).1
Capable of swallowing a capsule 3 cm in length (trial with 3 cm jelly candy)
Male or female
See 2 more

Exclusion Criteria

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
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Cytosponge procedure and traditional endoscopy for histological comparison

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedures

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: HistologyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Published Research Related to This Trial

The Cytosponge is a novel, patient-friendly device designed to efficiently sample the esophageal mucosa, showing promising results in detecting esophageal conditions compared to traditional endoscopy and biopsy methods.
High patient acceptability and the potential to reduce the need for costly endoscopic surveillance make the Cytosponge a significant advancement in the early detection of esophageal pathology, pending further validation in diverse populations.
Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review.Iqbal, U., Siddique, O., Ovalle, A., et al.[2019]
Sponge cytology is a highly effective and safe method for obtaining esophageal specimens, with 100% success in swallowing the sponge and satisfactory evaluation material from all participants.
The results showed that 86.6% of smears were negative for lesions, while 10% showed intestinal metaplasia, and 1.7% indicated high-grade lesions or squamous cell carcinoma, demonstrating good agreement with endoscopic findings and suggesting its potential as a primary screening tool in resource-limited settings.
Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya.Muriithi, RW., Muchiri, LW., Lule, GN.[2014]

Citations

Utility and Cost-Effectiveness of a Nonendoscopic ...Of 234 patients, Cytosponge adequately sampled the distal esophagus in 175 (75%). Of the 142 with both endoscopic and histologic data, 19 (13%) ...
Cytosponge®: a systematic review of multi-center dataCytosponge is a novel, minimally invasive esophageal cell collection device. We aimed to assess the data on safety and acceptability of this device.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30044236/
Safety and efficacy of a minimally invasive cell sampling ...The Cytosponge has been developed to sample the esophageal mucosa efficiently. The device is a compressed mesh sponge encapsulated in an ingestible gelatin ...
Use of a Minimally Invasive Cell Sampling Device...A total of 3 studies were evaluated the efficacy of the Cytosponge in diagnosing EoE and total of 4 studies evaluated the role of Cytosponge in the detection of ...
Use of a non-endoscopic immunocytological device ...Thirty-nine patients carried out the Cytosponge™ procedure successfully, with success rates exceeding 90% overall (95.1%, 95%CI 83.5-99.4) and in both the dCRT ...
Cytosponge™* Cell Collection DeviceRisk Information: Potential complications of the Cytosponge™* include: Mucosal laceration or perforation requiring secondary intervention, major and minor ...
an alternative to endoscopy in detecting Barrett esophagusThe Cytosponge is a small mesh sponge within a soluble gelatin capsule that can safely be administered orally by a nurse in primary care settings to collect ...
Accuracy, Safety, and Tolerability of Tissue Collection by ...In a feasibility study, the Cytosponge is a safe and well-tolerated method for collecting near mucosal specimens. Analysis of numbers of ...
Safety and Acceptability of Esophageal Cytosponge Cell ...Therefore, new, less invasive methods of esophageal mucosal sampling are. 149 being investigated. Cytosponge® is a minimally invasive cell collection device ...
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