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a/LCI-OCT Pilot in Esophagus

NCT04392167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-11-28

Study results available
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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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Adam Wax, Ph.D. · Professor

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2022-11-22
Completion
2022-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392167 on ClinicalTrials.gov