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

Summary

Objectives

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.