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A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the Cervix

View ORCID ProfileMercy N. Asiedu, Júlia S. Agudogo, Mary Elizabeth Dotson, Marlee S. Krieger, John W. Schmitt, View ORCID ProfileMegan Huchko, Gita Suneja, View ORCID ProfileRae Jean Proeschold-Bell, Jennifer S. Smith, Deborah Jenson, Wesley Hogan, Nirmala Ramanujam
doi: https://doi.org/10.1101/618348
Mercy N. Asiedu
1Department of Biomedical Engineering, Duke University, Durham, North Carolina, United States of America
2Center for Global Women’s Health Technologies, Duke University, Durham, North Carolina, United States of America
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
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  • ORCID record for Mercy N. Asiedu
  • For correspondence: mercy.asiedu@duke.edu
Júlia S. Agudogo
1Department of Biomedical Engineering, Duke University, Durham, North Carolina, United States of America
2Center for Global Women’s Health Technologies, Duke University, Durham, North Carolina, United States of America
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Mary Elizabeth Dotson
1Department of Biomedical Engineering, Duke University, Durham, North Carolina, United States of America
2Center for Global Women’s Health Technologies, Duke University, Durham, North Carolina, United States of America
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Marlee S. Krieger
1Department of Biomedical Engineering, Duke University, Durham, North Carolina, United States of America
2Center for Global Women’s Health Technologies, Duke University, Durham, North Carolina, United States of America
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John W. Schmitt
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
4Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina, United States of America
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Megan Huchko
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
4Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina, United States of America
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Gita Suneja
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
5Department of Radiation Oncology, Duke University, Durham, North Carolina, United States of America
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Rae Jean Proeschold-Bell
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
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  • ORCID record for Rae Jean Proeschold-Bell
Jennifer S. Smith
6Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina
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Deborah Jenson
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
7Department of Romance Studies, Duke University, Durham, North Carolina, United States of America
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Wesley Hogan
8Center for Documentary Studies, Duke University, Durham, North Carolina, United States of America
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Nirmala Ramanujam
1Department of Biomedical Engineering, Duke University, Durham, North Carolina, United States of America
2Center for Global Women’s Health Technologies, Duke University, Durham, North Carolina, United States of America
3Duke Global Health Institute, Duke University, Durham, North Carolina, United States of America
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Abstract

Background Invasive cervical cancer is preventable, yet affects 500,000 women worldwide each year, and over half these women die. Barriers to cervical cancer screening include lack of awareness of cervical cancer and the cervix, fear of the speculum, and lack of women-centric technologies. We developed a low-cost (∼$50), cervix-imaging device called the Callascope, which comprises an imaging component, camera and inserter that eliminates the need for a speculum and enables self-insertion. We sought to assess the quality of physicians’ images of the cervix using the Callascope versus the speculum in live patients and study women’s willingness to independently use the Callascope to image their cervix.

Methods We conducted two main studies: (1) a clinical study in which a physician imaged the cervix of patients using both the speculum and Callascope in a 2×2 crossover design; and (2) home-based self-cervix imaging with the Callascope.

Results Participants of the clinical study (n=28) and home study (n=12) all indicated greater comfort and an overall preference for the Callascope over the speculum. The clinical study data indicated that the Callascope enabled similar visualization compared to the speculum while significantly improving patient experience. With physician insertion and manipulation, the Callascope enabled cervix visualization for 82% of participants. In the home-study, 83% of participants were able to visualize their cervix with the Callascope on the first try and 100% after multiple attempts.

Conclusion The Callascope is more comfortable and provides similar visualization to the speculum. The Callascope can be used by medical providers for clinical exams while also enabling home self-screening for cervical cancer and promoting a better understanding of one’s cervix to increase awareness of cervical screening needs. The Callascope may increase cervical cancer screening rates through reducing barriers including cost, discomfort, lack of awareness and stigma.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted April 26, 2019.
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A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the Cervix
Mercy N. Asiedu, Júlia S. Agudogo, Mary Elizabeth Dotson, Marlee S. Krieger, John W. Schmitt, Megan Huchko, Gita Suneja, Rae Jean Proeschold-Bell, Jennifer S. Smith, Deborah Jenson, Wesley Hogan, Nirmala Ramanujam
bioRxiv 618348; doi: https://doi.org/10.1101/618348
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A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the Cervix
Mercy N. Asiedu, Júlia S. Agudogo, Mary Elizabeth Dotson, Marlee S. Krieger, John W. Schmitt, Megan Huchko, Gita Suneja, Rae Jean Proeschold-Bell, Jennifer S. Smith, Deborah Jenson, Wesley Hogan, Nirmala Ramanujam
bioRxiv 618348; doi: https://doi.org/10.1101/618348

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