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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that could simplify and enhance comfort during cervical cancer screening. Researchers aim to determine if this speculum-free device, known as the Introducer 'calla' device (also called Callascope or Pocket Colposcope), can detect early cervical issues using light-based technology. The trial consists of two parts: one involves healthy volunteers using the device at home or discussing their experiences, and the other involves using the device during regular Pap smears. Women who have had a pelvic exam and are comfortable speaking English might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform cervical cancer screening.

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 Speculum-Free Screening Device is safe for cervical cancer screening?

Research has shown that the Callascope can effectively view the cervix without a speculum. In doctor-administered exams, it succeeded 83% of the time, while in self-exams, it succeeded 95% of the time. The device is easy to use and affordable, making it a promising tool for cervical cancer screening, especially in resource-limited areas. Although detailed safety reports in humans are not yet available, the high success rates suggest the device is well-tolerated. Additionally, consideration of the Callascope for nurse-led cervical screening programs indicates confidence in its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Speculum-Free Screening Device for cervical cancer because it offers a more comfortable and less invasive alternative to traditional Pap smears. Unlike the standard use of a speculum, which can be uncomfortable for many women, this new introducer device allows for a potentially easier and more user-friendly experience during cervical cancer screening. Additionally, this approach may improve accessibility and encourage more women to undergo regular screenings, which is crucial for early detection and prevention. By focusing on comfort and ease of use, this device aims to transform how women perceive and participate in their reproductive health care.

What evidence suggests that the introducer 'calla' device is effective for cervical cancer screening?

Research has shown that the Callascope, which participants in this trial may use, can successfully visualize the cervix without a speculum. In doctor-conducted exams, it works 83% of the time, and in self-exams, it works 95% of the time. This device simplifies cervical screening and enhances comfort, which is crucial for detecting early signs of abnormal cell growth. Early findings suggest it might increase screening rates, particularly in resource-limited areas. The Callascope is easy to use and could transform cervical screenings, making them less invasive and more accessible. ^{1 2 3 5 6}

Who Is on the Research Team?

Nimmi Ramanujam, Ph.D.

Principal Investigator

Duke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-uterine-cervical-neoplasms-3-2016-f8b63

Speculum-Free Screening Device for Cervical Cancer Research shows that the Callascope can effectively visualize the cervix without a speculum, with 83% success in clinician exams and 95% in self-exams.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9651910/

An emerging paradigms on cervical cancer screening ... The effectiveness of screening did not significantly enhance when TruScreen and HPV testing were combined (7). Muszynski et al. performed a ...

3. callahealthfoundation.com callahealthfoundation.com/pocket-colposcope/

Introducing the Pocket Colposcope The new instrument with the potential to revolutionize cervical cancer screening in low-resource settings. · High Quality Imaging · User Friendly · Affordable.

4. researchgate.net researchgate.net/publication/353973566_Development_and_utilization_of_a_novel_cervical_visualization_tool_the_Callascope_for_home-based_self-exams

(PDF) Development and utilization of a novel cervical ... Results 10 out of 12 (83%) of participants were able to visualize their cervix with the Callascope on the first try during on-site training, and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40606949/

Feasibility of incorporating the Pocket colposcope into ... The study concluded that the Pocket colposcope is acceptable in nurse-led cervical cancer screening programs but emphasised the need for improvements in image ...

6. mdpi.com mdpi.com/2079-6374/12/10/786

Cervical Imaging in the Low Resource Setting: A Review This manuscript reviews uniquely cervical imaging devices for deployment in low-resource settings that can potentially be implemented for cervical cancer ...