Volumetric Laser Endomicroscopy’s (VLE) diagnostic accuracy validation study: Impact on clinical management Study
Phase I Completed on May 19th, 2019
Venue: Room Presidio A, San Diego Marriott Gaslamp Quarter, 660 K Street San Diego, CA 92101
7 am to 10 am PDT (Pacific Daylight Time)
Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management
Overall Primary Outcomes:
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Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity.
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Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
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Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.
Clips: 30 de-identified, OCT video clips featuring indeterminate biliary or pancreatic duct strictures with confirmed diagnoses
Phase I Design:
A survey form was sent to invited physicians. Form was accessed by laptop, tablet or phone.
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The physicians reviewed each clip for the presence or absence of the 9 key criteria, and selected their options on the survey form and submit.
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Set of criteria were checked (present or absent) during the scoring of the clips by the physicians.
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Revision of set criteria to be validated in Phase II
Phase II Ongoing December 2019
Objective: Validate Training Atlas and Intra-observer agreement for revised criteria
Primary Outcomes:
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Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity.
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Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.
Clips: 45 de-identified, OCT video clips featuring indeterminate biliary or pancreatic duct strictures with confirmed diagnoses
Phase II Design:
Training Atlas of videos and pictures featuring each criteria was reviewed by select physicians.
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The physicians will review each clip for the presence or absence of the revised key criteria, and submitted their selected their options on a survey form.
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Intra-observer agreement and accuracy will be calculated.
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Study PI: Dr. Michel Kahaleh
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Study Sub-I: Dr. Amy Tyberg, Dr. Viren Joshi
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Study Contact: Dr. Monica Gaidhane
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Study IRB: WIRB
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Study Sponsor: Ninepoint Medical
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Study Admin: Innovative Digestive Health Education & Research Inc (IDHER)
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ClinicalTrials.gov NCT: NCT03951324