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OCT Pilot in Esophagus

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ClinicalTrials.gov Identifier: NCT03434834
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. proportion of imaged sites correctly categorized as squamous or Barrett's mucosa [ Time Frame: at baseline ]
    proportion of imaged sites correctly categorized by OCT as squamous or Barrett's mucosa when compared to endoscopy


Secondary Outcome Measures :
  1. proportion of imaged sites with adequate tissue contact to acquire a high quality image [ Time Frame: at baseline ]
    proportion of imaged sites that achieved adequate tissue contact to acquire high quality OCT images



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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

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

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03434834     History of Changes
Other Study ID Numbers: Pro00090173
R01CA210544 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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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