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

Asiedu, M.; Agudogo, J. S.; Dotson, M. E.; Krieger, M. S.; Schmitt, J. W.; Huchko, M.; Suneja, G.; Proeschold-Bell, R. J.; Smith, J. S.; Jenson, D.; Hogan, W.; Ramanujam, N.

doi:10.1101/618348

bioRxiv · 10.1101/618348

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

Asiedu, M.·Agudogo, J. S.·Dotson, M. E.·Krieger, M. S.·Schmitt, J. W.·Huchko, M.·Suneja, G.·Proeschold-Bell, R. J.·Smith, J. S.·Jenson, D.·Hogan, W.·Ramanujam, N.

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Abstract

BackgroundInvasive 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 womens willingness to independently use the Callascope to image their cervix.\n\nMethodsWe 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 2x2 crossover design; and (2) home-based self-cervix imaging with the Callascope.\n\nResultsParticipants 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.\n\nConclusionThe 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 ones 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.

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Asiedu, M., Agudogo, J. S., Dotson, M. E., Krieger, M. S., Schmitt, J. W., Huchko, M., Suneja, G., Proeschold-Bell, R. J., Smith, J. S., Jenson, D., Hogan, W., Ramanujam, N.. 2019-04-26. A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the Cervix. https://doi.org/10.1101/618348

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