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

This study has been completed.
Sponsor:
Collaborators:
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01236300
First received: November 5, 2010
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Pancreatic Cysts
Intervention: Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
nCLE System Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).

Participant Flow:   Overall Study
    nCLE System  
STARTED     66  
COMPLETED     66  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
nCLE System Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).

Baseline Measures
    nCLE System  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Mean (Full Range)
  63.1  
  (27 to 89)  
Gender  
[units: participants]
 
Female     30  
Male     36  



  Outcome Measures
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1.  Primary:   Sensitivity   [ Time Frame: October 2011 ]

2.  Primary:   Specificity   [ Time Frame: October 2011 ]

3.  Primary:   PPV (Positive Predictive Value)   [ Time Frame: October 2011 ]

4.  Primary:   NPV (Negative Predictive Value)   [ Time Frame: October 2011 ]

5.  Secondary:   Overall Complication Rate   [ Time Frame: August 2011 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Vani J.A. Konda
Organization: University of Chicago Medical Center
phone: 773-702-1460
e-mail: vkonda@medicine.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01236300     History of Changes
Other Study ID Numbers: MKT-2010-INSPECT
EUSFNA_02 ( Other Identifier: Mauna Kea Technologies )
Study First Received: November 5, 2010
Results First Received: February 12, 2015
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)