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a/LCI-OCT Pilot in Esophagus

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ClinicalTrials.gov Identifier: NCT04392167
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 14, 2020
First Posted Date  ICMJE May 18, 2020
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE November 24, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
percentage of imaged sites correctly categorized as squamous or Barrett's mucosa [ Time Frame: day 1 ]
percentage of imaged sites correctly categorized by a/LCI-OCT as squamous or Barrett's mucosa when compared to endoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
percentage of imaged sites with adequate tissue contact to acquire a high quality image [ Time Frame: day 1 ]
percentage of imaged sites that achieved adequate tissue contact to acquire high quality a/LCI-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 a/LCI-OCT Pilot in Esophagus
Official Title  ICMJE Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study
Brief Summary This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe 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. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Barrett Esophagus
Intervention  ICMJE
  • Device: a/LCI-OCT imaging probe
    a/LCI and OCT imaging measurements of several locations in the esophagus
  • Procedure: esophageal biopsy
    biopsies of esophageal tissue imaged by a/LCI-OCT probe
Study Arms  ICMJE Experimental: a/LCI-OCT Imaging of the Esophagus
Interventions:
  • Device: a/LCI-OCT imaging probe
  • Procedure: esophageal biopsy
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: May 14, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presenting to University of North Carolina (UNC) for routine care upper endoscopy
  • Meet one of the following criteria:

    1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
    2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
    3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT04392167
Other Study ID Numbers  ICMJE Pro00090173_1
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
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • University of North Carolina, Chapel Hill
Investigators  ICMJE
Principal Investigator: Adam Wax, Ph.D. Professor
PRS Account Duke University
Verification Date December 2020

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