Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device

This study has been terminated.
(No patients enrolled; study terminated.)
Sponsor:
Collaborator:
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00503919
First received: July 17, 2007
Last updated: October 7, 2009
Last verified: September 2009
Results First Received: September 4, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Cervical Neoplasia
Intervention: Procedure: Multi-spectral Digital Colposcopy (MDC)

  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
Recruitment Period: 05/30/07 through 06/08/07. All participant recruitment attempted at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to time and device constraints, no patients were accrued.

Reporting Groups
  Description
Multi-spectral Digital Colposcopy Images Multi-spectral Digital Colposcopy (MDC) for Fluorescence Spectroscopy of Normal Cervix for Screening

Participant Flow:   Overall Study
    Multi-spectral Digital Colposcopy Images  
STARTED     0  
COMPLETED     0  
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.
No text entered.

Reporting Groups
  Description
Multi-spectral Digital Colposcopy Images Multi-spectral Digital Colposcopy (MDC) for Fluorescence Spectroscopy of Normal Cervix for Screening

Baseline Measures
    Multi-spectral Digital Colposcopy Images  
Number of Participants  
[units: participants]
  0  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     0  



  Outcome Measures

1.  Primary:   Multi-spectral Digital Colposcopy   [ Time Frame: Extra 2 minutes to image during routine colposcopy procedure ]


  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
Due to time and device constraints, no patients were accrued on this protocol. The type of device intended for usee to satisfy the clinical and/or scientific needs addressed in this research has changed.


  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: Andrea Milbourne, MD, MS, BA/Assoc. Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-6986


No publications provided


Responsible Party: Andrea Milbourne, MD, MS, BA/Assoc. Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00503919     History of Changes
Other Study ID Numbers: 2006-0810
Study First Received: July 17, 2007
Results First Received: September 4, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board