NCT00766701|CompletedDMC
Spectroscopic Evaluation of Cervical Neoplasia
Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
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Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
Sponsor study identifier
observational
1,599
1 country
7
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. The specific aims of the study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Actual (reported)September 2008
Actual (reported)October 3, 2008
Actual (reported)October 6, 2008
Actual (reported)Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia.
December 2008
A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.
Q1 2009
Procedure: Spectroscopy and Digital Imaging
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Double-blind, Prospective, Safety-efficacy study
University of Arkansas
Little Rock, Arkansas, 72205, United States
Orange Coast/Saddleback
Laguna Beach, California, 92653, United States
Saint Francis Hospital
Hartford, Connecticut, 06112, United States
University of Miami
Miami, Florida, 33136, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Texas
Dallas, Texas, 75390, United States
histology slides
Lisa Flowers, MD
Emory University/Grady Hospital System
1,599 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Thermal Imaging for Evaluation of the Cervix
Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia
Contact the study team to confirm eligibility.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
October 6, 2008
Record last verified: 2008-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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