RecruitingNot ApplicableNCT02947971

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System


Sponsor

Massachusetts General Hospital

Enrollment

120 participants

Start Date

Apr 15, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.


Eligibility

Min Age: 14 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a small swallowable capsule with an imaging device that takes pictures of the inside of the esophagus (food pipe), to see if this non-invasive technique can help screen for esophageal conditions like Barrett's esophagus (a pre-cancerous change), GERD (acid reflux), and eosinophilic esophagitis (inflammation of the food pipe). **You may be eligible if...** - You are 18 years or older and have a history of GERD (acid reflux) - Or you are 14 years or older and have a previous diagnosis of eosinophilic esophagitis (EoE) - Or you have a previous diagnosis of Barrett's esophagus - Or you are a healthy volunteer between 18 and 85 years old - You have had no solid food for at least 4 hours before the procedure **You may NOT be eligible if...** - You have an active esophageal disorder that would make swallowing the capsule unsafe - You are unable to swallow the capsule - You have not fasted as required before the procedure This swallowable capsule camera could make esophageal screening safer, more comfortable, and more accessible than traditional endoscopy. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental OFDI Imaging

Imaging of the esophagus with a compact OFDI system and distal scanning catheter


Locations(1)

Massachusetts General hospital

Boston, Massachusetts, United States

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NCT02947971


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