OCT Pilot in Esophagus

NCT ID: NCT03434834

Last Updated: 2021-04-06

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2020-03-25

Brief Summary

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This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.

Detailed Description

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Conditions

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Barrett Esophagus

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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OCT of esophagus

optical coherence tomography of esophagus

Group Type EXPERIMENTAL

optical coherence tomography

Intervention Type DEVICE

OCT measurements of 5 locations in the esophagus

Interventions

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optical coherence tomography

OCT measurements of 5 locations in the esophagus

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy
2. Meet one of the following criteria:

1. Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
3. Aged 18 to 80
4. Able to read, comprehend, and understand the informed consent document.

Exclusion Criteria

1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)
2. Pregnant women
3. Unable to provide written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Wax, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA210544

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00090173

Identifier Type: -

Identifier Source: org_study_id

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