SECM Capsule Imaging for Eosinophilic Esophagitis

Overseen By Nitasha Bhat, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inability to swallow, Esophageal fistula, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the SECM capsule safe for use in humans?

The SECM capsule, used for imaging the esophagus, is a swallowable device that does not require sedation or anesthesia, making it a relatively safe procedure. Similar capsule endoscopy devices have been used safely in both adults and children for various gastrointestinal conditions, with the main risk being capsule retention, which is rare and depends on the specific condition being evaluated. ^{1 2 3 4 5}

How does SECM Capsule Imaging differ from other treatments for eosinophilic esophagitis?

SECM Capsule Imaging is unique because it involves using a capsule to capture images of the esophagus, which is different from the common treatments like dietary changes and corticosteroids that focus on reducing inflammation. This imaging technique may help in better diagnosing and understanding the condition, rather than directly treating it. ^{6 7 8 9 10}

Research Team

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals aged 12 or older who are undergoing an endoscopic biopsy to evaluate Eosinophilic Esophagitis. Participants must be able to swallow pills and capsules, and cannot have esophageal strictures narrower than the capsule or esophageal fistula.

Inclusion Criteria

I am 12 or older and getting a biopsy to check for EoE.

Able to give informed consent

Exclusion Criteria

I have a narrow or blocked esophagus smaller than a capsule.

I cannot swallow pills or capsules.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SECM Capsule Imaging

Participants swallow the SECM capsule for imaging of the esophagus using a SECM optical system

1 day

1 visit (in-person)

Comparison and Analysis

Images obtained by the SECM capsule are compared to clinical endoscopy and biopsy images for research purposes

2-4 weeks

Follow-up

Participants are monitored for any adverse events post-procedure

4 weeks

Treatment Details

Interventions

• SECM capsule

Trial Overview The study is testing a new imaging technique called SECM Tethered Capsule Endoscopy (TCE) against the standard biopsy method for diagnosing Eosinophilic Esophagitis in the esophagus.

Participant Groups

Group I: SECM capsule imaging Experimental Treatment 1 Intervention

Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tethered confocal endomicroscopy capsule for diagnosis and monitoring of eosinophilic esophagitis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Capsule endoscopy in pediatrics: a 10-years journey. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Resolution of remodeling in eosinophilic esophagitis correlates with epithelial response to topical corticosteroids. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A miniaturized, tethered, spectrally-encoded confocal endomicroscopy capsule. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Capsule endoscopy--state of the art. [2007]

6. Romania pubmed.ncbi.nlm.nih.gov

[Eosinophilic esophagitis--from a rare pediatric disease to the forefront of adult gastroenterology]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Eosinophilic esophagitis: trials and tribulations. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

A comprehensive review of eosinophilic esophagitis in adults. [2011]

9. France pubmed.ncbi.nlm.nih.gov

[Eosinophilic esophagitis: an "emerging disease"]. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

Eosinophilic esophagitis: a newly established cause of dysphagia. [2022]