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

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

How does the CervImage Device treatment for cervical dysplasia differ from other treatments?

The CervImage Device for cervical dysplasia is unique because it likely offers a non-invasive or minimally invasive approach compared to traditional surgical methods like cone biopsy or LEEP, which involve removing tissue. This could mean less risk of complications such as scarring or cervical stenosis (narrowing), which are associated with more invasive procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the design and engineering of a new minimally invasive medical imaging device (CervImage™). Investigators are trying to find out if CervImage™ is reliable and easy to use to obtain clinical 3D photographs and to record 3D measurements in human cervixes. Investigators then plan to use these images to determine if CervImage™ design and engineering improvements need to be made.

Research Team

Isaiah Johnson, MD

Principal Investigator

Carilion Clinic

Eligibility Criteria

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

I am between 21 and 70 years old.

Participants able to consent for themselves

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Cervical cerclage and evidence-based medicine: if, how and when]. [2007]

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

Risk of persistent or recurrent neoplasia in conservatively treated women with cervical adenocarcinoma in situ with negative histological margins. [2017]

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

Evaluation of a new instrument designed for directed cervical excision: cone biopsy excisor. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Obstetric outcomes in patients who have undergone excisional treatment for high-grade cervical squamous intra-epithelial neoplasia. [2022]

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

Cervical obstruction complicating second-trimester abortion: treatment with misoprostol. [2021]