N/A
Completed N=37
a/LCI-OCT Pilot in Esophagus
Source: ClinicalTrials.gov NCT04392167 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Percentage of Correctly Identified Positive (Dysplastic) Biopsies — 100.0 percentage of correct identifications
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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
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. Informational only — not medical advice.