SECM Capsule Imaging for Eosinophilic Esophagitis

Recruiting in Palo Alto (17 mi)

Overseen byGuillermo Tearney, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

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.

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.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: SECM capsule imagingExperimental Treatment1 Intervention

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