Back to resultsOCT Pilot in Esophagus
Primary Purpose
Barrett Esophagus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
optical coherence tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
- Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
- 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,
- History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
- 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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OCT of esophagus
Arm Description
optical coherence tomography of esophagus
Outcomes
Primary Outcome Measures
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Secondary Outcome Measures
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
Full Information
NCT ID
NCT03434834
First Posted
January 29, 2018
Last Updated
March 12, 2021
Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03434834
Brief Title
OCT Pilot in Esophagus
Official Title
Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCT of esophagus
Arm Type
Experimental
Arm Description
optical coherence tomography of esophagus
Intervention Type
Device
Intervention Name(s)
optical coherence tomography
Intervention Description
OCT measurements of 5 locations in the esophagus
Primary Outcome Measure Information:
Title
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Description
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Time Frame
at baseline
Title
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Description
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Description
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
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,
History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Wax, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
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OCT Pilot in Esophagus
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