OCT Pilot in Esophagus

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Device: optical coherence tomography

• Registration Number: NCT03434834
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Study Start: 2018-09-25
• Primary Completion: 2020-02-25
• Study Completion: 2020-03-25
• Results First Submitted: 2021-02-19
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Results First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

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Exclusion Criteria

1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)
2. Pregnant women
3. Unable to provide written informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT of esophagus	optical coherence tomography	optical coherence tomography of esophagus

Primary Outcome Measures

Name	Time	Method
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa	at baseline	Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa	at baseline	Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

Secondary Outcome Measures

Name	Time	Method
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image	at baseline	Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States