OFDI Capsule Imaging for Barrett's Esophagus

Recruiting in Palo Alto (17 mi)

Overseen byGuillermo Tearney, MD, PhD

Age: 18+

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 purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

Eligibility Criteria

This trial is for adults over 18 who can consent to participate and are scheduled for an EGD, a type of esophagus examination. It's not suitable for those with narrowings (strictures) in the esophagus, bleeding disorders, or those taking certain blood-thinning medications including NSAIDs.

Inclusion Criteria

I am over 18 years old.

I am scheduled for an upper GI endoscopy.

Patients must be able to give informed consent

Exclusion Criteria

I have a narrowing in my esophagus.

I am taking blood thinners or NSAIDs currently.

I have a history of bleeding or clotting disorders.

Participant Groups

The study is evaluating a new capsule-based technology called OFDI Capsule Marking to diagnose Barrett's Esophagus. This involves swallowing a capsule that captures detailed images of the esophagus lining during an EGD procedure.

1Treatment groups

Experimental Treatment

Group I: OFDI Capsule Marking and ImagingExperimental Treatment1 Intervention

Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.