Status:

COMPLETED

In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors

Lead Sponsor:

University of Chicago

Collaborating Sponsors:

Mauna Kea Technologies

Institut Paoli-Calmettes

Conditions:

Pancreatic Cysts

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinou...

Detailed Description

The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the di...

Eligibility Criteria

Inclusion

  • Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
  • Patients aged 18 years or older,
  • Patients is under surgical consideration for management of the cyst
  • Patients have provided written informed consent for the study

Exclusion

  • Allergy to fluorescein
  • Pregnancy or breast-feeding

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2012

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT01236300

Start Date

July 1 2010

End Date

May 1 2012

Last Update

June 8 2016

Active Locations (1)

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1

University of Chicago

Chicago, Illinois, United States, IL 60637