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NCT04392167 · ClinicalTrials.gov registry record · NA
a/LCI-OCT Pilot in Esophagus
A NA study of Barrett Esophagus, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04392167: Completed NA study of Barrett Esophagus, sponsored by Duke University.
NCT04392167 is a NA study of Barrett Esophagus that has completed, run by Duke University. The registered enrollment target is 37 participants, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04392167, a NA study of Barrett Esophagus, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.
Conditions Studied
Interventions
- DEVICE a/LCI-OCT imaging probe
- PROCEDURE esophageal biopsy
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2022-11-29 |
| Phase | NA |
What the finished NCT04392167 record still lists
NCT04392167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 3,564-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Barrett Esophagus appearing as the primary indexed condition, and to 2 interventions - of which a/LCI-OCT imaging probe is the first listed.
NCT04392167 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04392167 about?
NCT04392167 is a clinical study titled "a/LCI-OCT Pilot in Esophagus". 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)...
What is the current status of trial NCT04392167?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2020-11-24. Estimated completion is 2022-11-29.
What conditions does trial NCT04392167 study?
This clinical trial studies the following conditions: Barrett Esophagus.
What interventions are being tested in trial NCT04392167?
The interventions under investigation include: a/LCI-OCT imaging probe (DEVICE), esophageal biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04392167?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04392167 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barrett Esophagus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04392167's enrollment target sits among peer trials
37 27th of 32 higher than 6 of 32 other Barrett Esophagus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
RECRUITING · NA
-
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
RECRUITING · NA
-
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
RECRUITING · NA
-
Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus
RECRUITING · NA
-
Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus
RECRUITING · NA
-
Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance
RECRUITING · NA
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