RESEARCH

Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

  • 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 | NCT03951324

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria.


This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

Objective: 
Validate diagnostic impact of VLE diagnostic accuracy on clinical management


Primary Objectives:

  1. Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (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.


Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (Screening and Treatment)


Investigators: Up to 30 Expert and non-expert endoscopists currently using VLE