← Back to Search

OFDI Capsule Imaging for Barrett's Esophagus

N/A

Waitlist Available

Led By Guillermo Tearney, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be over the age of 18

Patients must be undergoing an EGD

Must not have

Patients with esophageal strictures

Patients who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up it is expected that the total experimental time including swallowing the ofdi capsule ofdi, ofdi imaging, and removal of the ofdi capsule will take approximately 20 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new imaging capsule that may help diagnose Barrett's Esophagus, a condition that can lead to esophageal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from swallowing the capsule, risk of capsule retention if there are unknown strictures, and possible minor throat irritation from the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Select...

I am scheduled for an upper GI endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a narrowing in my esophagus.

Select...

I am taking blood thinners or NSAIDs currently.

Select...

I have a history of bleeding or clotting disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ it is expected that the total experimental time including swallowing the ofdi capsule ofdi, ofdi imaging, and removal of the ofdi capsule will take approximately 20 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~it is expected that the total experimental time including swallowing the ofdi capsule ofdi, ofdi imaging, and removal of the ofdi capsule will take approximately 20 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and it is expected that the total experimental time including swallowing the ofdi capsule ofdi, ofdi imaging, and removal of the ofdi capsule will take approximately 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis

Secondary study objectives

Sensitivity of the marking OFDI Capsule to correctly detect and mark the region of interest in BE

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met