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History of Changes for Study: NCT04392167
a/LCI-OCT Pilot in Esophagus
Latest version (submitted November 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 14, 2020 None (earliest Version on record)
2 July 1, 2020 Study Status
3 September 3, 2020 Study Status
4 October 5, 2020 Recruitment Status, Study Status and Contacts/Locations
5 December 1, 2020 Study Status
6 October 13, 2021 Study Status
7 June 3, 2022 Study Status
8 November 4, 2022 Study Status
Comparison Format:

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Study NCT04392167
Submitted Date:  May 14, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00090173_1
Brief Title: a/LCI-OCT Pilot in Esophagus
Official Title: Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study
Secondary IDs: R01CA210544 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Not yet recruiting
Study Start: June 2020
Primary Completion: October 2021 [Anticipated]
Study Completion: October 2021 [Anticipated]
First Submitted: May 14, 2020
First Submitted that
Met QC Criteria:
May 14, 2020
First Posted: May 18, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 14, 2020
Last Update Posted: May 18, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Duke University
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Barrett Esophagus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: a/LCI-OCT Imaging of the Esophagus 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Adam Wax, Ph.D.
Telephone: 919-660-5143
Email: a.wax@duke.edu
Study Officials: Adam Wax, Ph.D.
Principal Investigator
Professor
Locations: United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact:Contact: Nicholas J Shaheen, M.D. 919-955-2513 nicholas_shaheen@med.unc.edu
Contact:Principal Investigator: Nicholas J Shaheen, M.D.
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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