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

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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 |
Inclusion Criteria:
- Presenting to University of North Carolina (UNC) for routine care upper endoscopy
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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

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
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Adam Wax, Ph.D. | Professor |
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 |
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 |
Barrett Esophagus Precancerous Conditions Neoplasms |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |