N/A N=53 Diagnostic

OCT Pilot in Esophagus

Barrett Esophagus

Bottom Line

View on ClinicalTrials.gov: NCT03434834 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa — 93.1 percentage of imaged sites

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: optical coherence tomography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa	93.1	—
PRIMARY Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa	84.6	—
SECONDARY Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image	80.5	—

Summary

This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained 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.

Eligibility Criteria

Inclusion Criteria

Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03434834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.