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Imaging Device

OFDI Capsule Imaging for Barrett's Esophagus

N/A
Recruiting
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
Subjects must be over the age of 18 but less than 70 year of age.
A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
Must not have
Subjects with the inability to swallow pills and capsules.
Subjects over 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-7 minutes of imaging
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new type of medical imaging system that is smaller and easier to use. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults aged 18-70 who can swallow pills and have been diagnosed with Barrett's Esophagus (BE), or are healthy volunteers. Participants must not eat solid food for 4 hours and only clear liquids for 2 hours before the procedure. Pregnant individuals, those over 70, with a strong gag reflex, esophageal fistula/strictures smaller than the capsule cannot join.
What is being tested?
The study is testing a new type of imaging using an Optical Frequency Domain Imaging (OFDI) capsule that scans the esophagus. It aims to check how easy and safe it is to use this compact system in people with BE or healthy subjects before a larger trial.
What are the potential side effects?
Potential side effects may include discomfort from swallowing the OFDI capsule or mild irritation in the esophagus during imaging. However, since this is about testing feasibility and safety, detailed side effects will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have been diagnosed with Barrett's esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot swallow pills or capsules.
Select...
I am over 70 years old.
Select...
I have a narrow or blocked esophagus smaller than a capsule.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-7 minutes of imaging
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 minutes of imaging for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of quality and performance of Compact Imaging System (CIS)

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 ImagingExperimental Treatment1 Intervention
Experimental OFDI Imaging

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,985 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,340 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,816 Previous Clinical Trials
8,161,719 Total Patients Enrolled

Media Library

Experimental OFDI Imaging (Imaging Device) Clinical Trial Eligibility Overview. Trial Name: NCT02947971 — N/A
Barrett's Esophagus Research Study Groups: OFDI Imaging
Barrett's Esophagus Clinical Trial 2023: Experimental OFDI Imaging Highlights & Side Effects. Trial Name: NCT02947971 — N/A
Experimental OFDI Imaging (Imaging Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947971 — N/A
~2 spots leftby Dec 2025
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