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OCT Pilot in Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434834
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE September 25, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
proportion of imaged sites correctly categorized as squamous or Barrett's mucosa [ Time Frame: at baseline ]
proportion of imaged sites correctly categorized by OCT as squamous or Barrett's mucosa when compared to endoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03434834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
proportion of imaged sites with adequate tissue contact to acquire a high quality image [ Time Frame: at baseline ]
proportion of imaged sites that achieved adequate tissue contact to acquire high quality OCT images
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OCT Pilot in Esophagus
Official Title  ICMJE Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An Optical Coherence Tomography (OCT) Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Barrett Esophagus
Intervention  ICMJE Device: optical coherence tomography
OCT measurements of 5 locations in the esophagus
Study Arms  ICMJE Experimental: OCT of esophagus
optical coherence tomography of esophagus
Intervention: Device: optical coherence tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03434834
Other Study ID Numbers  ICMJE Pro00090173
R01CA210544 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • University of North Carolina, Chapel Hill
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Adam Wax, Ph.D. Professor
PRS Account Duke University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP