Back to resultsa/LCI-OCT Pilot in Esophagus
Primary Purpose
Barrett Esophagus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
a/LCI-OCT imaging probe
esophageal biopsy
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:
- Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
- History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
- 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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a/LCI-OCT Imaging of the Esophagus
Arm Description
Outcomes
Primary Outcome Measures
percentage of imaged sites correctly categorized as squamous or Barrett's mucosa
percentage of imaged sites correctly categorized by a/LCI-OCT as squamous or 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 a/LCI-OCT images
Full Information
NCT ID
NCT04392167
First Posted
May 14, 2020
Last Updated
December 8, 2022
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI), University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04392167
Brief Title
a/LCI-OCT Pilot in Esophagus
Official Title
Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI), University of North Carolina, Chapel Hill
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 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.
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
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a/LCI-OCT Imaging of the Esophagus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
a/LCI-OCT imaging probe
Intervention Description
a/LCI and OCT imaging measurements of several locations in the esophagus
Intervention Type
Procedure
Intervention Name(s)
esophageal biopsy
Intervention Description
biopsies of esophageal tissue imaged by a/LCI-OCT probe
Primary Outcome Measure Information:
Title
percentage of imaged sites correctly categorized as squamous or Barrett's mucosa
Description
percentage of imaged sites correctly categorized by a/LCI-OCT as squamous or Barrett's mucosa when compared to endoscopy
Time Frame
day 1
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 a/LCI-OCT images
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
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
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
Plan to Share IPD
No
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a/LCI-OCT Pilot in Esophagus
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