OCT Pilot in Esophagus

March 12, 2021 updated by: Duke University

Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT of esophagus
optical coherence tomography of esophagus
Device: optical coherence tomography
OCT measurements of 5 locations in the esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Time Frame: at baseline
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
at baseline
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Time Frame: at baseline
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Time Frame: at baseline
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Adam Wax, Ph.D., Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

March 25, 2020

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00090173
  • R01CA210544 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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