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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\u2019s 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.<\/jats:p><jats:p><jats:italic>Clinical study registration<\/jats:italic> ClinicalTrials.gov <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/record\/\">https:\/\/clinicaltrials.gov\/ct2\/show\/record\/<\/jats:ext-link> NCT00900575, Pan African Clinical Trial Registry (PACTR) <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.pactr.org\/\">https:\/\/www.pactr.org\/<\/jats:ext-link> PACTR201905806116817.<\/jats:p>","DOI":"10.1038\/s41598-020-72219-9","type":"journal-article","created":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T10:04:27Z","timestamp":1601978667000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system"],"prefix":"10.1038","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct00900575","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"pactr201905806116817","registry":"10.18810\/pactr"}],"author":[{"given":"Mercy N.","family":"Asiedu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00falia S.","family":"Agudogo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary E.","family":"Dotson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Skerrett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlee S.","family":"Krieger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher T.","family":"Lam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doris","family":"Agyei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliet","family":"Amewu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwaku","family":"Asah-Opoku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Huchko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John W.","family":"Schmitt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Samba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Srofenyoh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirmala","family":"Ramanujam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,6]]},"reference":[{"key":"72219_CR1","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1001\/jama.2018.10897","volume":"320","author":"Forece, U. 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They and other team members (JSA, ESk, CTL) have developed technologies related to this work where the investigators or Duke may benefit financially if this system is sold commercially. For the concept of this system a patent has been awarded to MNA, JSA, CTL and NR with the title: \"Colposcopes and mammoscopes having curved ends and flat ends, associated methods, and speculum-free imaging methods\". U.S. Patent Application No. 16\/089,522. This does not alter the authors' adherence to Scientific Report\u2019s policies on sharing data and materials. Other authors declare no competing interets.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"16570"}}