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OpenTrials
Completed

NCT Number: NCT03434834

OCT Pilot in Esophagus

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Prior esophageal surgery (uncomplicated nissen fundoplication OK)
  • Pregnant women
  • Unable to provide written informed consent

Treatment and study plan

optical coherence tomography

Device

OCT measurements of 5 locations in the esophagus

Primary outcomes

  1. Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa

    Time frame: at baseline

    Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.

  2. Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa

    Time frame: at baseline

    Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.

Secondary outcomes

  1. Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image

    Time frame: at baseline

    Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2018
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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