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Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures

NCT02736708 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2020-08-26

No results posted yet for this study

Summary

Primary sclerosing cholangitis (PSC)

1. Prospectively validate interpretation criteria for the characterization of PSC strictures
2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures (differentiation between malignant vs. non malignant strictures), using the newly developed interpretation criteria
3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DEVICE

probe based confocal laser endomicroscopy

real-time, microscopic imaging of tissue at the cellular level via a small diameter probe.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Northwell Health

    collaborator OTHER

  • Methodist Health System

    collaborator OTHER

  • Ochsner Health System

    collaborator OTHER

  • Mauna Kea Technologies

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Raj Shah, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-12-31
Completion
2020-05-31

Countries

  • United States

Study Locations

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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 NCT02736708 on ClinicalTrials.gov