Schmitt, J. W. | bioRxiv Science

bioRxiv2019

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

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.

clinical trials↗

bioRxiv2018

Development of algorithms for automated detection of cervical pre-cancers with a low-cost, point-of-care, Pocket Colposcope

GoalIn this work, we propose methods for (1) automatic feature extraction and classification for acetic acid and Lugols iodine cervigrams and (2) methods for combining features/diagnosis of different contrasts in cervigrams for improved performance.\n\nMethodsWe developed algorithms to pre-process pathology-labeled cervigrams and to extract simple but powerful color and textural-based features. The features were used to train a support vector machine model to classify cervigrams based on corresponding pathology for visual inspection with acetic acid, visual inspection with Lugols iodine, and a combination of the two contrasts.\n\nResultsThe proposed framework achieved a sensitivity, specificity, and accuracy of 81.3%, 78.6%, and 80.0%, respectively when used to distinguish cervical intraepithelial neoplasia (CIN+) relative to normal and benign tissues. This is superior to the average values achieved by three expert physicians on the same data set for discriminating normal/benign cases from CIN+ (77% sensitivity, 51% specificity, 63% accuracy).\n\nConclusionThe results suggest that utilizing simple color- and textural-based features from visual inspection with acetic acid and visual inspection with Lugols iodine images may provide unbiased automation of cervigrams.\n\nSignificanceThis would enable automated, expert-level diagnosis of cervical pre-cancer at the point-of-care.

bioinformatics↗