Study to Image the Esophagus Using the OFDI Capsule

NCT ID: NCT02204150

Last Updated: 2019-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-07-31

Brief Summary

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The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Detailed Description

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A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Conditions

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Barrett's Esophagus Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OFDI Capsule Imaging

Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system.

Group Type EXPERIMENTAL

OFDI Capsule

Intervention Type DEVICE

Imaging of the esophagus using the OFDI Capsule and system

Interventions

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OFDI Capsule

Imaging of the esophagus using the OFDI Capsule and system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A previous diagnosis of Barrett's Esophagus
* OR a previous diagnosis of EoE
* OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
* Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
* Subject must be able to give informed consent

Exclusion Criteria

* Subjects with known esophageal strictures, intestinal strictures or dysphagia
* OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Tearney

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Tearney, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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5R01CA103769-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011P002619

Identifier Type: -

Identifier Source: org_study_id

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