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N/A N=37 Diagnostic

a/LCI-OCT Pilot in Esophagus

Barrett Esophagus

Bottom Line

View on ClinicalTrials.gov: NCT04392167 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Correctly Identified Positive (Dysplastic) Biopsies — 100.0 percentage of correct identifications

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
a/LCI-OCT imaging probe (Device); esophageal biopsy (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Nov 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Correctly Identified Positive (Dysplastic) Biopsies		 100.0 —
PRIMARY
Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies		 93.0 —
SECONDARY
Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image		 83.8 —

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 Criteria

Inclusion Criteria

  • 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

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 (NCT04392167). 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.

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