LuViva Advanced Cervical Scan for Cervical Dysplasia

Recruiting at 3 trial locations

Overseen By Mark Faupel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Guided Therapeutics

Must not be taking: Fluoroquinolones, Retinoids

Disqualifiers: Pregnancy, Hysterectomy, Photosensitizing diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have recently used photosensitizing agents like fluoroquinolones or retinoids.

How is the LuViva Advanced Cervical Scan treatment different from other treatments for cervical dysplasia?

The LuViva Advanced Cervical Scan is unique because it is a non-invasive diagnostic tool that uses light to detect cervical dysplasia, unlike traditional methods that often require tissue samples or biopsies. This approach can provide immediate results without the need for laboratory processing, making it a potentially quicker and less invasive option compared to standard biopsy procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for women who can consent, have had a Pap test within the last 120 days, and are scheduled for colposcopy based on certain risk guidelines. It's not for those who are pregnant, have had radiation therapy to the pelvic area in the past year, lack a cervix due to hysterectomy, or have conditions that could interfere with testing.

Inclusion Criteria

I am scheduled for a colposcopy due to a moderate risk of severe cervical changes.

Able to read or understand and give informed consent

Referral Pap test within 120 days

Exclusion Criteria

I have not had radiation therapy to my urinary or genital organs in the last year.

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

My cervix is easily irritated or bleeds.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the LuViva test followed by standard and enhanced colposcopy procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• LuViva Advanced Cervical Scan

Trial Overview The study tests if the LuViva Advanced Cervical Scan can accurately categorize women into low or high risk of cervical disease after abnormal screening results. This may help decide if they need more thorough exams and biopsies to detect serious cervical changes.

Participant Groups

Group I: Singe-arm Study Experimental Treatment 1 Intervention

Experimental device being evaluated for sensitivity and specificity.

Who Is Running the Clinical Trial?

Guided Therapeutics

Lead Sponsor

Trials

3

Recruited

2,800+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Ancillary Techniques in Cervical Biopsy and Endocervical Curettage Specimens as Follow-Up to Papanicolaou Test Results Indicating a Diagnosis of Atypical Squamous Cells, Cannot Exclude High-Grade Squamous Intraepithelial Lesion, or High-Grade Squamous Intraepithelial Lesion. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Carbon dioxide laser in the treatment of premalignant lesions of the cervix (author's transl)]. [2013]

3. Bulgaria pubmed.ncbi.nlm.nih.gov

[IS THERE A PLACE FOR VIA AND VILI IN OUR PRACTICE]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of careHPV, hybrid capture 2 and visual inspection with acetic acid for detection of high-grade cervical lesion in Tanzania: A cross-sectional study. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of papanicolaou smear and human papillomavirus (HPV) test as cervical screening tools: can we rely on HPV test alone as a screening method? An 11-year retrospective experience at a single institution. [2020]