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

Launched by GUIDED THERAPEUTICS · Jun 2, 2021

Keywords

ClinConnect Summary

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 o...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Able to read or understand and give informed consent
• • Referral Pap test within 120 days
• • Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.\*
• • Notes: The rationale for defining the referral inclusion criteria as women scheduled for colposcopy is that this group has been identified with having a significant likelihood of being diagnosed with CIN2+ over the two year period after being referred to colposcopy because of an abnormal screening test or tests. For example, the ALTS results showed that women with ASC-US plus high-risk HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10% to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been shown that this threshold also carries with it a 4% or greater likelihood of immediate CIN3+ (12).
• Exclusion Criteria:
• • Pregnancy
• • Menstruating on the day of colposcopy and LuViva test
• • Radiation therapy to her genitourinary system within 1 year
• • Prior hysterectomy in which cervix was removed
• • Congenital anatomical cervical variant (e.g., double cervix)
• • Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
• • Post-coital or other significant bleeding at the time of the exam
• • Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the Investigator, to interfere with a Pap test or colposcopy, resulting from inflammation, bacterial infection or other sources
• • History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
• • Undergoing phototherapy
• • Recent use of photosensitizing agents, such as fluoroquinolones or retinoids
• • Under-screened populations - defined as those women who have not been screened within the past 5 years who also screen positive for any HPV genotype