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A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

NCT00779688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2011-02-10

No results posted yet for this study

Summary

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Conditions

Interventions

DEVICE

Probe-based confocal laser endomicroscopy

ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Sponsors & Collaborators

  • Cellvizio Inc.

    collaborator INDUSTRY

  • Emissary International LLC

    collaborator INDUSTRY

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Yang Chen, MD, FACP, FACG · University of Colorado, Denver

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-09-30
Completion
2010-10-31

Countries

  • United States
  • France
  • Germany

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 NCT00779688 on ClinicalTrials.gov