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OCT Pilot in Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434834
Recruitment Status : Completed
First Posted : February 15, 2018
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: optical coherence tomography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : March 25, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: OCT of esophagus
optical coherence tomography of esophagus
 Device: optical coherence tomography
OCT measurements of 5 locations in the esophagus


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434834


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Adam Wax, Ph.D. Professor
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] January 9, 2018
Study Protocol and Statistical Analysis Plan  [PDF] April 14, 2020

More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03434834    
Other Study ID Numbers: Pro00090173
R01CA210544 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2018    Key Record Dates
Results First Posted: April 6, 2021
Last Update Posted: April 6, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases