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a/LCI-OCT Pilot in Esophagus

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ClinicalTrials.gov Identifier: NCT04392167
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: a/LCI-OCT imaging probe Procedure: esophageal biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 a/LCI-Optical Coherence Tomography (OCT) Pilot Study
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: a/LCI-OCT Imaging of the Esophagus Device: a/LCI-OCT imaging probe
a/LCI and OCT imaging measurements of several locations in the esophagus

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


Outcome Measures
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Primary Outcome Measures :
  1. percentage of imaged sites correctly categorized as squamous or Barrett's mucosa [ Time Frame: day 1 ]
    percentage of imaged sites correctly categorized by a/LCI-OCT as squamous or 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: day 1 ]
    percentage of imaged sites that achieved adequate tissue contact to acquire high quality a/LCI-OCT images


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT04392167


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
National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Adam Wax, Ph.D. Professor
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04392167    
Other Study ID Numbers: Pro00090173_1
R01CA210544 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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