Clinical trial · Interventional
OCT Pilot in Esophagus
Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
NCT03434834CI-TRIAL-00051072completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| optical coherence tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OCT of esophagus
- description
- optical coherence tomography of esophagus
- interventionNames
- Device: optical coherence tomography
Primary outcomes (2)
- measure
- Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
- timeFrame
- at baseline
- description
- Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
- measure
- Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
- timeFrame
- at baseline
- description
- Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy 2. Meet one of the following criteria: 1. 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, 2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+ 3. Aged 18 to 80 4. Able to read, comprehend, and understand the informed consent document. Exclusion Criteria: 1. Prior esophageal surgery (uncomplicated nissen fundoplication OK) 2. Pregnant women 3. Unable to provide written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.