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

Status: Enrolling by invitation
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Time Frame
Start Date: November 24, 2020
Estimated Completion Date: October 2022
Participants
Target number of participants: 40
Treatments
Experimental: a/LCI-OCT Imaging of the Esophagus
Authors
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
Leads: Duke University

This content was sourced from clinicaltrials.gov

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