Status:
ENROLLING_BY_INVITATION
The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
Lead Sponsor:
Guided Therapeutics
Conditions:
Cervical Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 determin...
Detailed Description
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 subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04915495
Start Date
May 5 2023
End Date
July 31 2025
Last Update
March 21 2025
Active Locations (4)
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1
University of Alabama Birmingham- Heersink School of Medicine
Birmingham, Alabama, United States, 35233
2
Emory University- Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Great Lakes Bay Health Centers
Bay City, Michigan, United States, 48706
4
Tidewater Clinical Research
Norfolk, Virginia, United States, 23502