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

NCT03951324 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Stricture
  • Pancreas Cancer
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Bile Duct Neoplasms Malignant
  • Bile Duct Neoplasms
  • Bile Duct Lesions
  • Bile Duct Obstruction
  • Bile Duct Diseases
  • Bile Duct Obstruction, Extrahepatic
  • Bile Duct Stenosi
  • Bile Duct Adenoma
  • Pancreatic Duct Stricture
  • Pancreatic Duct Stenosis
  • Pancreatic Duct Obstruction
  • Pancreatic Ductal Adenocarcinoma
  • Primary Sclerosing Cholangitis

Interventions

OTHER

Interobserver agreement or Interrater agreement

Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

Sponsors & Collaborators

  • NinePoint Medical

    collaborator INDUSTRY

  • Innovative Digestive Health Education and Research Inc

    lead OTHER

Principal Investigators

  • Michel Kahaleh, MD · Innovative Digestive Health Education and Research Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03951324 on ClinicalTrials.gov