Speculum-Free Screening Device for Cervical Cancer

(Calla Trial)

Overseen By Jennifer Gallagher, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

305 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.

What data supports the effectiveness of the treatment Introducer 'calla' device, Callascope, Pocket Colposcope for cervical cancer screening?

Research shows that the Callascope can effectively visualize the cervix without a speculum, with 83% success in clinician exams and 95% in self-exams. Participants also preferred it over traditional methods, indicating it is a viable and more comfortable option for cervical imaging. ^{1 2 3 4 5}

Is the speculum-free screening device for cervical cancer safe for humans?

The Callascope, a speculum-free device for cervical imaging, has been tested in clinical studies and was found to be a viable option for both clinician-based and self-exams, with participants preferring it over traditional speculum exams. No specific safety concerns were reported in these studies. ^{2 3 4 6 7}

How is the Callascope treatment different from other cervical cancer screening methods?

The Callascope is unique because it allows for cervical cancer screening without using a speculum, which many women find uncomfortable. It is a low-cost, portable device that can be used by both clinicians and women themselves for self-exams, making it more accessible and less intimidating than traditional methods. ^{1 2 3 4 8}

What is the purpose of this trial?

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Research Team

Nimmi Ramanujam, Ph.D.

Principal Investigator

Duke

Eligibility Criteria

This trial is for healthy women aged 21-65 who speak English well enough to have a conversation. Participants should have had a pelvic exam before and must not be pregnant. Their education level may also be considered.

Inclusion Criteria

Have conversational proficiency in English

I am a healthy woman.

I am between 21 and 65 years old.

Exclusion Criteria

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

The introducer 'Calla' is used during routine Pap smears for cervical cancer screening and at-home use by healthy volunteers

1 week

1 visit (in-person) for patients, at-home use for healthy volunteers

Follow-up

Participants are monitored through interviews and surveys to assess the preference for the introducer over the standard speculum

1 week

Treatment Details

Interventions

• Introducer 'calla' device

Trial Overview The study is testing a new device called 'calla' for cervical cancer screening without the need for a speculum, alongside interviews. It aims to identify specific optical patterns that indicate abnormal tissue changes.

Participant Groups

Group I: Patient surveillance Experimental Treatment 1 Intervention

The introducer will be used during annual Pap smears for cervical cancer screening.

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix.

Introducer 'calla' device is already approved in United States for the following indications:

Approved in United States as Callascope for:

• Cervical cancer screening

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Korle-Bu Teaching Hospital, Accra, Ghana

Collaborator

Trials

11

Recruited

9,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The POCkeT colposcope, a low-cost intravaginal imaging device, showed comparable performance to a standard colposcope in interpreting cervical images, with an average agreement of 70% among physicians in the first protocol involving 44 patients.

After modifications, the POCkeT colposcope achieved a 55% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), indicating its potential as a viable option for cervical cancer screening in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope. Mueller, JL., Asma, E., Lam, CT., et al.[2022]

The Callascope, a new low-cost tool for cervical imaging, allows for both clinician and self-examinations without the discomfort of a speculum, showing comparable visualization results to standard exams (83% vs. 100% for clinicians).

Clinical studies indicated a high feasibility and willingness among women to use the Callascope for self-imaging, with 95% successfully visualizing their cervix and a preference for the Callascope over traditional speculum exams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. Asiedu, MN., Agudogo, JS., Dotson, ME., et al.[2022]

The study introduces a tampon-sized inserter and the POCkeT Colposcope as a comfortable, speculum-free alternative for cervical cancer screening, showing high safety and effective visualization of the cervix in various uterine positions.

Testing with 15 volunteers revealed that 83% achieved adequate cervix visualization, and 92.3% preferred the inserter over the traditional speculum, highlighting its potential for self-screening and improved comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening. Asiedu, MN., Agudogo, J., Krieger, MS., et al.[2022]

The POCkeT Colposcope, a low-cost and portable device designed like a tampon, can capture high-quality images of the cervix comparable to traditional colposcopes, making it suitable for cervical cancer screening.

This innovative technology aims to improve access to cervical cancer screening in low- and middle-income countries by enabling community health workers to perform screenings, addressing the shortage of trained professionals and facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. Lam, CT., Krieger, MS., Gallagher, JE., et al.[2022]

Both the Generation 3 and Generation 4 Pocket Colposcopes showed significantly higher image contrast compared to a standard-of-care colposcope, making them effective tools for cervical cancer screening.

The Generation 4 Pocket Colposcope not only maintained image quality but also reduced electrical power needs and included waterproof features, enhancing its suitability for use in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis. Lam, CT., Mueller, J., Asma, B., et al.[2022]

Cervical cancer incidence is significantly lower in screened populations (less than 0.1%) compared to unscreened populations (2-4%), highlighting the importance of screening for cervical dysplasia.

The development of a portable, electricity-free binocular colposcope offers a practical solution for cervical screening in low-resource settings, potentially improving access to necessary healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable colposcopy in low-resource settings. Walmer, DK., Merisier, D., Littman, E., et al.[2020]

A web-based colposcopy quality assurance program showed a high level of diagnostic agreement among colposcopists, with overall agreement rates of 72% for colposcopic impressions and 87% for the need for biopsy, indicating effective training and consistency in evaluations.

The study found that regional differences in colposcopists' training backgrounds had only minor effects on diagnostic agreement, suggesting that colposcopy interpretation can be reliably reproduced across different training levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpretation of colposcopy in population-based cervical screening services in north-eastern Italy: an online interregional agreement study. Garutti, P., Cristiani, P., Fantin, GP., et al.[2017]

The Gynocular, a pocket-sized battery-driven colposcope, demonstrated a 70.1% agreement with standard colposcopy in diagnosing cervical lesions, indicating it can be a reliable alternative for cervical assessments.

In a study involving 69 women, the Gynocular's performance was validated against biopsy results, showing it effectively identifies cervical lesions, which is crucial for early detection of conditions like cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement of colposcope and gynocular in assessment of cervical lesions by swede score: a randomized, crossover pilot trial. Ngonzi, J., Bajunirwe, F., Wistrand, C., et al.[2013]

References

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

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. [2022]

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

Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening. [2022]

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

Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. [2022]

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

An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis. [2022]

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

Portable colposcopy in low-resource settings. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Interpretation of colposcopy in population-based cervical screening services in north-eastern Italy: an online interregional agreement study. [2017]

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

Agreement of colposcope and gynocular in assessment of cervical lesions by swede score: a randomized, crossover pilot trial. [2013]