The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia

Overview

This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and High risk groups for the purpose of determining whether they require enhanced colposcopy and additional biopsies in order to increase detection of CIN2+ cervical disease.

This study is a matched pair design, single-arm study with the following two treatments: current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test, all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the colposcopist noting on the case report form (CRF), locations of lesions with colposcopy impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that include the use on Lugol's solution and green/blue filters. The colposcopist will note on the CRF any additional lesions that became evident as a result of these enhanced measures, regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies identified using SOC practices will be placed in vials labeled "SOC Samples". Biopsies identified using enhanced practices will be placed in vials labeled "Additional Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar junction (SCJ) in which a lesion was not observed. These biopsies will be placed in the vial labeled "Additional Samples". Once all colposcopy procedures are completed, biopsies of lesions collected, and biopsies of any non-lesion identified quadrants collected, an ECC, if indicated, will be collected. If an ECC would have been taken per SOC practices, it will be placed in a vial labeled "SOC ECC". ECCs collected per enhanced procedures will be placed in a vial labeled "Additional ECC". The study is a matched pair design because all subjects are tested with the LuViva device, and all will undergo both the nominal (minimal) colposcopy and biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be determined 1) Whether enhanced procedures can be justified when the LuViva test indicates High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk, that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for increased detection of CIN2+. Subjects will be enrolled during their normally scheduled colposcopy visit and will be recruited from the pool of patients that are referred to colposcopy based on the ASCCP Guidelines published in April 2020. The total number of enrolled female subjects pooled across all clinical sites combined will not exceed 500 in order to target an evaluable cohort of approximately 400 women.

Conditions

Interventions

Eligibility

Locations (4)

Outcomes