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

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ClinicalTrials.gov Identifier: NCT03951324
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
NinePoint Medical
Information provided by (Responsible Party):
Innovative Digestive Health Education and Research Inc

Tracking Information
First Submitted Date May 13, 2019
First Posted Date May 15, 2019
Last Update Posted Date August 12, 2019
Actual Study Start Date May 10, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2019)
  • Interobserver agreement and diagnostic accuracy [ Time Frame: 2 months ]
    Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity
  • Frequency and type of criteria visually identified on malignant VLE clips [ Time Frame: 2 months ]
    Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03951324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 13, 2019)
Number of procedures needed to view and conduct to use VLE for diagnostic confirmation [ Time Frame: 2 months ]
Learning curve using CUSUM analysis to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management proficiently.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Official Title Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Brief 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.

Detailed Description

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.

B. 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)

Study Design (2 phase):

  • Phase 1: Primary Objective 1 and 2 part of the study will be completed.
  • Phase 2: Primary Objective 3 of the study will be conducted within 1 month.

Study Timeline: 3 months post WIRB approval. Sample size: 40 VLE Clips of at least 20 seconds featuring one or more the VLE criteria. All clips will have confirmed diagnosis for accuracy analysis. All clips will be de-identified. All clips will be removed from RedCAP and other secure cloud storage upon completion of study.

Clips will be supplied by NinePoint Medical, the company behind VLE OCT. All VLE clips will be from a dataset of clips collected from adults > 18 and who underwent Endoscopic retrograde cholangiopancreatography (ERCP) with indeterminate biliary stricture indications. The clips are chosen based on the quality of the clips, duration, final diagnosis and presence of either benign or malignant criteria.

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

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology.

Endoscopists who use VLE to diagnose indeterminate biliary or pancreatic duct strictures.

Condition
  • 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
Intervention 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
Study Groups/Cohorts
  • Expert Endoscopists
    Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures
    Intervention: Other: Interobserver agreement or Interrater agreement
  • None-Expert Endoscopists
    Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures
    Intervention: Other: Interobserver agreement or Interrater agreement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 13, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951324
Other Study ID Numbers 2565207-44318141
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Innovative Digestive Health Education and Research Inc
Study Sponsor Innovative Digestive Health Education and Research Inc
Collaborators NinePoint Medical
Investigators
Principal Investigator: Michel Kahaleh, MD Innovative Digestive Health Education and Research Inc
PRS Account Innovative Digestive Health Education and Research Inc
Verification Date August 2019