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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 years old.
Select...
I am scheduled for an upper GI endoscopy.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the marking OFDI capsule for diagnosing BE by comparing OFDI images and biopsy diagnosis
Secondary outcome measures
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
2,918 Previous Clinical Trials
13,192,705 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,516 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,552 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a narrowing in my esophagus.I am over 18 years old.I am scheduled for an upper GI endoscopy.I am taking blood thinners or NSAIDs currently.I have a history of bleeding or clotting disorders.
Research Study Groups:
This trial has the following groups:- Group 1: OFDI Capsule Marking and Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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