Speculum-Free Screening Device for Cervical Cancer
(Calla Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Pregnancy
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
23467How 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.
12348Eligibility 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.
+2 more
Exclusion Criteria
Pregnant women
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Patient surveillanceExperimental Treatment1 Intervention
The introducer will be used during annual Pap smears for cervical cancer screening.
Group II: Healthy VolunteersExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
Korle-Bu Teaching Hospital, Accra, GhanaCollaborator
National Cancer Institute (NCI)Collaborator
References
International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope. [2022]Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.
A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. [2022]Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope's ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging.Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.
Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening. [2022]Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy.
Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. [2022]Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies.
An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis. [2022]We have previously developed a portable Pocket Colposcope for cervical cancer screening in resource-limited settings. In this manuscript we report two different strategies (cross-polarization and an integrated reflector) to improve image contrast levels achieved with the Pocket Colposcope and evaluate the merits of each strategy compared to a standard-of-care digital colposcope. The desired outcomes included reduced specular reflection (glare), increased illumination beam pattern uniformity, and reduced electrical power budget. In addition, anti-fogging and waterproofing features were incorporated to prevent the Pocket Colposcope from fogging in the vaginal canal and to enable rapid disinfection by submersion in chemical agents.
Portable colposcopy in low-resource settings. [2020]Screening for cervical dysplasia is an important public health effort worldwide. In unscreened populations, the incidence of cervical cancer ranges between 2 and 4% of the adult female population, whereas less than 0.1% of the screened population of Caucasian women has cervical cancer in the United States. In developing countries, cervical cytology is difficult to implement successfully because of the cost, cultural constraints, limited access to pathology services, etc. Bypassing cytology and going directly to colposcopy has been successfully implemented as a screening strategy for dysplasia in low resource settings. In this article we describe the development and utilization of a portable binocular colposcope that does not require electricity.
Interpretation of colposcopy in population-based cervical screening services in north-eastern Italy: an online interregional agreement study. [2017]An innovative web-based colposcopy quality assurance programme was implemented in population-based cervical screening services in three north-eastern Italian administrative regions with different colposcopists' training background. In this study, the levels of intra- and interregional intercolposcopist diagnostic agreement were evaluated.
Agreement of colposcope and gynocular in assessment of cervical lesions by swede score: a randomized, crossover pilot trial. [2013]This study aimed to determine if criterion standard colposcopy could be provided by a pocket-sized battery-driven colposcope, the Gynocular.