LuViva Advanced Cervical Scan for Cervical Dysplasia

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new scanning device called LuViva, which assists doctors in determining whether women with abnormal cervical screening tests require more detailed exams or biopsies. The goal is to better identify those who may have serious cervical changes, known as CIN2+. Women with abnormal Pap tests who are already scheduled for a closer examination called a colposcopy might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to advancing medical technology that could enhance cervical health assessments.

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.

What prior data suggests that the LuViva Advanced Cervical Scan is safe for cervical dysplasia screening?

Research has shown that the LuViva Advanced Cervical Scan is a non-invasive tool using light to detect abnormal cell growth on the cervix, known as cervical dysplasia. This means it doesn't require surgery or any invasive procedures.

Importantly, the device identifies the risk of a pre-cancerous condition called cervical intraepithelial neoplasia (CIN). Since the scan is non-invasive, most people find it easy to tolerate, and no significant side effects have been reported from its use.

The device aims to help doctors more accurately identify women who may need further testing. This trial phase focuses on the device's effectiveness, suggesting that its safety is already well-established.

In summary, LuViva is designed to be safe and gentle, assisting doctors in deciding if more tests are needed without causing discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cervical dysplasia, which often involves Pap smears and HPV testing, the LuViva Advanced Cervical Scan offers a non-invasive, real-time scanning method. This device is unique because it uses light-based technology to identify changes in cervical tissue, aiming to improve sensitivity and specificity over traditional diagnostic methods. Researchers are excited about this technology because it has the potential to provide quicker and more accurate results, reducing the need for multiple follow-up procedures and minimizing patient discomfort.

What evidence suggests that the LuViva Advanced Cervical Scan is effective for detecting cervical dysplasia?

Research has shown that the LuViva Advanced Cervical Scan might detect cervical cancer earlier than traditional Pap and HPV tests. This device, evaluated in a single-arm study, uses multimodal hyperspectral imaging to identify women at higher risk of cervical disease. New data presented at a European conference highlighted its ability to detect cervical issues sooner, potentially leading to better health outcomes. Although some studies mention a lack of strong evidence regarding its effectiveness, the promising early results suggest that LuViva could be a useful tool in cervical cancer screening. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04915495

The Use of the LuViva Advanced Cervical Scan to Identify ... This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4781255/

DySIS, LuViva Advanced Cervical Scan and Niris Imaging ... There is no reliable evidence on the clinical effectiveness of LuViva and Niris. DySIS plus colposcopy appears to be less costly and more effective than ...

3. guidedinc.com guidedinc.com/new-data-released-at-european-conference-demonstrates-luviva-advanced-cervical-scan-detects-cervical-cancer-earlier-than-pap-and-hpv-tests/

New Data Released at European Conference ... New Data Released at European Conference Demonstrates LuViva® Advanced Cervical Scan Detects Cervical Cancer Earlier than Pap and HPV tests.

4. withpower.com withpower.com/trial/phase-uterine-cervical-dysplasia-5-2021-f774c

LuViva Advanced Cervical Scan for Cervical Dysplasia This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able to segregate women with abnormal screening tests into Low and ...

5. newmars-technologies.com newmars-technologies.com/luviva-advanced-cervical-scan/

The LuViva Advanced Cervical Scan Though these tests has proven effective in reducing the number of women dying worldwide from cervical cancer, these tests refer a high percentage of women onto ...

6. fcc.report fcc.report/FCC-ID/2AAAW-13500/2122465.pdf

User's Manual LuViva® Advanced Cervical Scan Model ... Safety Information-Warnings, Cautions and Symbols. This section contains information regarding Warnings, Cautions and Safety Symbols for LuViva. Review these.

7. luvivaeurope.com luvivaeurope.com/about-the-device/

About the device - LuViva Europe The LuViva's results indicate the likelihood of cervical intraepithelial neoplasia II or greater (CIN II+) within the scanned area as Low, Moderate, or High.