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:

  1. Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity.

  2. Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)

  3. 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.

  • 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.

  • Set of criteria were checked (present or absent) during the scoring of the clips by the physicians.

  • 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:

  1. Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity.

  2. 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.

  • 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.

  • Intra-observer agreement and accuracy will be calculated.

 

  • Study PI: Dr. Michel Kahaleh

  • Study Sub-I: Dr. Amy Tyberg, Dr. Viren Joshi

  • Study Contact: Dr. Monica Gaidhane

  • Study IRB: WIRB

  • Study Sponsor: Ninepoint Medical

  • Study Admin: Innovative Digestive Health Education & Research Inc (IDHER)

  • ClinicalTrials.gov NCT: NCT03951324

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