Duke University researchers have developed a handheld device for cervical cancer screening that produces high-quality images on a smartphone or laptop, part of an initiative to make screenings more accessible, easier to conduct and less costly than studies using expensive traditional equipment.

The wand-like device, which is portable and simple to use, captures high-quality images of the cervix. In fact, the pocket colposcope rivals the image quality of the best colposcopes on the market but at a fraction of the weight, size and cost, contends Nimmi Ramanujam, the Robert W. Carr, Jr., Professor of Biomedical Engineering at Duke.

According to Ramanujam, current standard practices for cervical cancer screening require a speculum (a metal device designed to spread the vaginal walls apart), a colposcope (a magnified telescopic device and camera designed to enable medical professionals to see the cervix), as well as a highly trained professional to administer the test. As a result, she notes that cervical cancer is more prevalent in women living in low socioeconomic communities that do not have access to these resources.

“The mortality rate of cervical cancer should absolutely be zero percent because we have all the tools to see and treat it—but, it isn’t,” says Ramanujam. “That is in part because women do not receive screening or do not follow up on a positive screening to have colposcopy performed at a referral clinic. We need to bring colposcopy to women so that we can reduce this complicated string of actions."

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The device, which was developed with funding from the National Institutes of Health, has a colposcope design that resembles a pocket-sized tampon with lights and a camera at one end. It also includes an inserter through which the colposcope can be inserted to make the entire procedure speculum free. The channel through the inserter is also accessible to contrast agents used for the cervical cancer screening procedure.

Researchers are working on automating the screening process by using image processing and machine learning to teach computers how to spot signs of precancerous and cancerous cells. Ultimately, Ramanujam believes women could use the device to self-screen, eliminating the need for a trained physician, and thereby potentially transforming screening and cure rates worldwide.

The genesis for the device was a trip that Ramanujam, who is director of the Center for Global Women’s Health Technologies at Duke, made to Tanzania in which clinicians in that country reported difficulties in getting women screened for cervical cancer in the developing country because of uncomfortable speculums.

“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,” write Ramanujam and her colleagues in a May 31 article in the journal PLOS One. “This study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection.”

In their study of 15 volunteers at Duke, with self-insertion and physician-assisted cervix image capture, adequate cervix visualization for 83 percent of patients was demonstrated, while 92.3 percent of women reported that they preferred the speculum-free cervical cancer screening afforded by the device.

The pocket colposcope has been tested with a speculum in clinical trials in the United States, Kenya, Peru and Tanzania, with about 500 patients enrolled to date. New studies are planned in Honduras and Zambia. The speculum-free version has been recently introduced into a 50-patient study; it will assess how the speculum-free device compares with standard speculum-based gynecology for visualization of the cervix.

“We’ve applied for additional funding from the NIH to continue these efforts,” Ramanujam concludes, while noting that the team is working on regulatory clearance for the device, which they hope to receive by the end of 2017.

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