Development and Application of a Multispectral Digital Colposcopy Algorithm for Detection of Cervical Intraepithelial Neoplasia and Neoplasia.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Detection of cancer or pre-cancerous abnormalities of the cervix by multispectral digital colposcope.
All study subjects will be evaluated for cervical abnormalities by 1) standard colposcopy and 2) the trial device (multispectral digital colposcope + wand). Results from each device will be compared, both in terms of the presence/absence of abnormalities and the stage/grade of abnormalities detected by both tools. Histopathological review for cervical abnormalities will be taken as the gold standard against which standard colposcopy and trial device results are measured.
Standard colposcopy and trial device (MDC + wand) results will be obtained during the clinic visit. Histopathological results for comparison will be available within a few days of the clinic visit.
Michele Follen, MD, PhD
United States: Institutional Review Board