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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

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
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I am over 18 years old.
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I am scheduled for an upper GI endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a narrowing in my esophagus.
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I am taking blood thinners or NSAIDs currently.
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I have a history of bleeding or clotting disorders.

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
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

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,591 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,381 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,870 Total Patients Enrolled

Media Library

OFDI Capsule Marking Clinical Trial Eligibility Overview. Trial Name: NCT02422433 — N/A
Barrett's Esophagus Research Study Groups: OFDI Capsule Marking and Imaging
Barrett's Esophagus Clinical Trial 2023: OFDI Capsule Marking Highlights & Side Effects. Trial Name: NCT02422433 — N/A
OFDI Capsule Marking 2023 Treatment Timeline for Medical Study. Trial Name: NCT02422433 — N/A
~13 spots leftby Dec 2025
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