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a/LCI-OCT Pilot in Esophagus

NCT ID: NCT04392167

Last Updated: 2023-11-28

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2022-11-29

Brief Summary

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This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe 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. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.

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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a/LCI-OCT Imaging of the Esophagus

Group Type EXPERIMENTAL

a/LCI-OCT imaging probe

Intervention Type DEVICE

a/LCI and OCT imaging measurements of several locations in the esophagus

esophageal biopsy

Intervention Type PROCEDURE

biopsies of esophageal tissue imaged by a/LCI-OCT probe

Interventions

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a/LCI-OCT imaging probe

a/LCI and OCT imaging measurements of several locations in the esophagus

Intervention Type DEVICE

esophageal biopsy

biopsies of esophageal tissue imaged by a/LCI-OCT probe

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus
* Aged 18 to 80
* Able to read, comprehend, and understand the informed consent document

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

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

References

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Terry NG, Zhu Y, Rinehart MT, Brown WJ, Gebhart SC, Bright S, Carretta E, Ziefle CG, Panjehpour M, Galanko J, Madanick RD, Dellon ES, Trembath D, Bennett A, Goldblum JR, Overholt BF, Woosley JT, Shaheen NJ, Wax A. Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. Gastroenterology. 2011 Jan;140(1):42-50. doi: 10.1053/j.gastro.2010.09.008. Epub 2010 Sep 18.

Reference Type BACKGROUND
PMID: 20854820 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA210544

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00090173_1

Identifier Type: -

Identifier Source: org_study_id