NCT04392167

a/LCI-OCT Pilot in Esophagus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-11-22
• Completion: 2022-11-29
• First posted: 2020-05-18
• Last updated: 2023-11-28
• Results posted: 2023-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study