IMproved PRactice Outcomes and Value Excellence in Colposcopy (IMPROVE-COLPO)
|ClinicalTrials.gov Identifier: NCT02185599|
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : November 29, 2017
The study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan.
The study will collect colposcopy data across multiple sites in two arms; a prospective arm, with DySIS being used for the examination and a retrospective arm, with data retrieved from patient charts.
|Condition or disease||Intervention/treatment|
|High Grade Cervical Intraepithelial Neoplasia||Device: DySIS|
Each site will contribute data to both arms; the study will collect data on demographics, disease yield, number of biopsies and treatment decisions. Study subjects will receive standard of care procedures and management.
Prospective data will be collected at colposcopy examinations performed using the DySIS digital colposcope on consecutive patients that have been referred for colposcopy after a positive screening test. Retrospective data on colposcopy examinations performed using a standard colposcope will be collected from patient medical records, to capture standard practice to-date as a control for comparisons. The retrospective data will be collected from consecutive examinations performed by the providers participating in the prospective arm and for the preceding year.
|Study Type :||Observational|
|Actual Enrollment :||7529 participants|
|Official Title:||IMproved PRactice Outcomes and Value Excellence in Colposcopy|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 9, 2017|
|Actual Study Completion Date :||October 9, 2017|
Colposcopy with DySIS
The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
Colposcopy performed with the DySIS digital colposcope
The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.
- Number of subjects diagnosed with CIN2+ cervical lesions [ Time Frame: At time of colposcopy ]Changes in number of subjects diagnosed with CIN2+ cervical lesions
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185599
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