OCT Pilot in Esophagus

Barrett Esophagus Clinical Trial

Official title:

Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434834
• Other study ID #: Pro00090173
• Secondary ID: R01CA210544
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: March 25, 2020

Study information

• Verified date: March 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Device:
• optical coherence tomography
OCT measurements of 5 locations in the esophagus

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa	Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.	at baseline
Primary	Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa	Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.	at baseline
Secondary	Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image	Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.	at baseline