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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-7 minutes of imaging
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I haven't eaten solid food for 4 hours and only had clear liquids for 2 hours before the procedure.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of quality and performance of Compact Imaging System (CIS)

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
13,627 Previous Clinical Trials
40,927,375 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,403 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,683 Previous Clinical Trials
6,930,838 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current population size for this research trial?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical trial was first introduced on April 15th 2016 and is currently recruiting participants. A total of 20 patients are required across 1 site for the study's completion."

Answered by AI

Are new participants being admitted to this research initiative?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical examination, which was initially released on April 15th 2016, is presently searching for volunteers. Approximately 20 subjects need to be sourced from 1 distinct healthcare facility."

Answered by AI

Does this experiment extend to adults who are over 25 years old?

"All participants are expected to be between 18 and 70 years of age."

Answered by AI

Who would be the ideal candidate for this clinical experiment?

"This study is recruiting up to 20 people suffering from barrett esophagus who are aged 18-70. Candidates must adhere to a strict 4 hour fast with 2 hours of clear liquids prior to the procedure in order to be eligible for enrollment."

Answered by AI
~2 spots leftby Mar 2025