Status:
COMPLETED
OCT Pilot in Esophagus
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18-80 years
Phase:
NA
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 iden...
Eligibility Criteria
Inclusion
- Presenting to University of North Carolina (UNC) for routine care upper endoscopy
- Meet one of the following criteria:
- 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,
- History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
- Aged 18 to 80
- Able to read, comprehend, and understand the informed consent document.
Exclusion
- Prior esophageal surgery (uncomplicated nissen fundoplication OK)
- Pregnant women
- Unable to provide written informed consent
Key Trial Info
Start Date :
September 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03434834
Start Date
September 25 2018
End Date
March 25 2020
Last Update
April 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599