CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
a/LCI-OCT imaging probe +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04392167
NCT04392167N/ACompleted

Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study

Duke University·interventional·Posted May 18, 2020·Updated Nov 28, 2023

In Brief

A clinical study evaluating a/LCI-OCT imaging probe and esophageal biopsy for Barrett Esophagus. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 18, 2020
Enrollment StartNov 24, 2020
Primary CompletionNov 22, 2022
Study CompletionNov 29, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.1 years ago

Interventions

a/LCI-OCT imaging probedevice

a/LCI and OCT imaging measurements of several locations in the esophagus

esophageal biopsyprocedure

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