High Grade Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
IMproved PRactice Outcomes and Value Excellence in Colposcopy
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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