CervImage Device for Cervical Dysplasia

(CervImage Trial)

Overseen By Isaiah Johnson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Cognitive impairment, Pregnant, Incarcerated, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging device called CervImage™, designed to capture 3D images of the cervix. The goal is to determine if the device is reliable and easy to use for detecting cervical dysplasia, a condition characterized by abnormal cell growth on the cervix. The trial seeks women who have or have had HPV (a common virus that can lead to cervical cancer) or cervical intraepithelial neoplasia, as well as a few healthy participants without these conditions. Participants will assist researchers in assessing whether the device requires improvements before broader use. As an unphased trial, this study offers participants the opportunity to contribute to the development of innovative diagnostic tools.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CervImage device is safe for cervical imaging?

Research shows that the CervImage device is a new tool for capturing 3D images of the cervix to help doctors detect abnormal cells early. The device is minimally invasive, causing little to no discomfort. Specific information about side effects from using CervImage is not available, as the trial is in a "Not Applicable" phase. This phase typically focuses on testing the device's construction and functionality rather than its safety. This suggests the device is expected to be safe and easy to use, similar to other medical imaging tools. Those with concerns about joining the trial should consult their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CervImage device because it offers a novel approach to detecting cervical intraepithelial dysplasia (CIN) using advanced imaging technology. Unlike traditional methods like Pap smears and standard colposcopies, which can sometimes miss abnormalities or require multiple visits, the CervImage device aims to enhance the precision of cervical imaging. This could potentially lead to earlier and more accurate detection of cervical dysplasia, which is crucial for effective intervention and treatment. By improving the visualization of the cervix, this device could streamline the diagnostic process and reduce the need for invasive procedures.

What evidence suggests that the CervImage device is effective for cervical dysplasia?

Research shows that artificial intelligence (AI) can detect abnormal cell growth on the cervix with greater accuracy. Recent studies found that AI was 98% effective in identifying high-risk cervical conditions. It surpassed experienced doctors in accuracy when using colposcopy, a test that closely examines the cervix. This trial will evaluate the CervImage™ device, which uses advanced imaging, to determine its effectiveness in early and accurate detection of cervical issues. ^{1 5 6 7 8}

Who Is on the Research Team?

Isaiah Johnson, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with cervical conditions like cancer, dysplasia, or neoplasia. The study aims to include a diverse group of participants to test the CervImage device's effectiveness in screening.

Inclusion Criteria

Participants able to consent for themselves

I am between 21 and 70 years old.

I have an HPV infection or cervical pre-cancer.

Exclusion Criteria

Any condition which in the clinical judgement of the PI makes the subject unsuitable or unsafe for study enrollment

Cognitive Impairment

Currently Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo a gynecologic exam with the CervImage™ device integrated into the procedure

Less than 5 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate feedback and evaluation of the CervImage™ device

Immediately after the procedure

What Are the Treatments Tested in This Trial?

Interventions

• CervImage device

Trial Overview The trial is testing the CervImage™ device's ability to take clinical 3D photographs and measurements of the human cervix. It will assess if this new technology can improve cervical neoplasia screening in areas with limited resources.

How Is the Trial Designed?

Group I: CervImage Device Experimental Treatment 1 Intervention

CervImage device for cervical imaging to detect cervical intraepithelial dysplasia \[CIN\] via colposcopy

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Pensievision, Inc

Collaborator

Trials

1

Recruited

20+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cervical cerclage is a key treatment for cervical insufficiency, which can lead to second trimester abortions or preterm deliveries, and can be performed either prophylactically or therapeutically depending on the woman's history and cervical condition.

While cervical cerclage is widely used, there is still a lack of controlled trials to definitively prove its advantages over a 'wait and see' approach, although laparoscopic cerclage has shown promising safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cervical cerclage and evidence-based medicine: if, how and when]. Patella, A., Pergolini, I., Custo, G., et al.[2007]

In a study of 360 women treated conservatively for adenocarcinoma-in-situ (AIS) with negative surgical margins, there was a low but significant risk of persistent or recurrent cervical neoplasia, with 1.9% diagnosed with high-grade lesions and 2.8% with AIS during follow-up.

The median follow-up time was 3.9 years, indicating that while conservative treatments like CKC and LEEP are fertility-preserving options, ongoing monitoring is essential due to the potential for neoplasia despite initial negative margins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of persistent or recurrent neoplasia in conservatively treated women with cervical adenocarcinoma in situ with negative histological margins. Munro, A., Codde, J., Spilsbury, K., et al.[2017]

The Cone Biopsy Excisor (CBE) procedure resulted in a significantly higher rate of single specimens (87%) compared to the standard loop electrosurgical excision procedure (LEEP) (17%), indicating better specimen quality for histological evaluation.

CBE also demonstrated less thermal damage to the cervical tissue, with a mean thermal damage score of 4.1 compared to 6.1 for LEEP, suggesting that CBE may provide clearer margins for diagnosis and reduce the risk of indeterminate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new instrument designed for directed cervical excision: cone biopsy excisor. Scribner, DR., Fischer, NR., Gagliardi, S., et al.[2019]

Excisional treatment for high-grade cervical intra-epithelial neoplasia (CIN2+) significantly increases the risk of preterm delivery, with rates of 33.13% in treated women compared to 6.60% in untreated women, based on a study of 2316 women.

Techniques that remove more tissue, like large loop excision, are associated with worse obstetric outcomes, including higher risks of premature rupture of membranes and dystocic births, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric outcomes in patients who have undergone excisional treatment for high-grade cervical squamous intra-epithelial neoplasia. Maina, G., Ribaldone, R., Danese, S., et al.[2022]

In two cases of women with a history of cervical LEEP and significant cervical obstruction, the administration of misoprostol effectively softened the cervix, allowing for successful dilation and evacuation of the uterus.

This approach demonstrated that misoprostol can be a safe and effective alternative to surgical procedures like hysterotomy in cases where cervical scarring or obstruction complicates abortion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical obstruction complicating second-trimester abortion: treatment with misoprostol. Borgatta, L., Sayegh, R., Betstadt, SJ., et al.[2021]

Citations

1. withpower.com withpower.com/trial/cervimage-device-for-cervical-dysplasia-71ff6

CervImage Device for Cervical Dysplasia The Cone Biopsy Excisor (CBE) procedure resulted in a significantly higher rate of single specimens (87%) compared to the standard loop electrosurgical excision ...

2. nature.com nature.com/articles/s41598-024-51880-4

Development and validation of artificial intelligence-based ... In a multicenter retrospective study, CerviCARE AI achieved a remarkable sensitivity of 98% for high-risk groups (P2, P3, HSIL or higher, CIN2 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025003059

Efficacy of photodynamic therapy for cervical intraepithelial ... Based on the results of 44 patients with complete follow-up data, the total efficacy for CIN 3 was 85.19% (23/27) for ALA-PDT treatment, 100% (3/3) for PDT ...

4. opg.optica.org opg.optica.org/abstract.cfm?URI=ao-63-28-7499

Effective cervical intraepithelial neoplasia classification ... Moreover, the F score F 1 score for the CIN2 category has improved from 0.718 to 0.761, and the F score F 1 score for the CIN3 category has ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00571-6/fulltext

Performance of artificial intelligence for diagnosing cervical ... Compared with experienced colposcopists, AI demonstrated superior accuracy in colposcopic examinations (odds ratio (OR) 1.75; 95% CI 1.33–2.31; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389460/

Computer-aided diagnosis of cervical dysplasia using ... Using a computer-aided diagnosis system, physicians could identify cancer/HSIL with greater sensitivity, which guided biopsy to take timely treatment.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04154644

Study Details | NCT04154644 | Performance, Safety, and ... Once proven safe, feasible and effective, CryoPop could save tens of thousands of lives in low- and middle-income countries each year by preventing cervical ...

8. ecfr.gov ecfr.gov/current/title-21/chapter-I/subchapter-H/part-864/subpart-B/section-864.1865

21 CFR 864.1865 -- Cervical intraepithelial neoplasia (CIN ... (E) Device stability data, including real-time stability and shipping stability under various storage times, temperatures, and freeze-thaw conditions. (F) Data ...