The researchers of Duke University have established a handheld device for cervical cancer screenings that produces high-quality images on a smartphone or laptop, part of an initiative to make screenings more accessible, convenient to conduct and less expensive than studies using costly traditional equipment.
The wand-like device, which is portable and easier to use, captures high-quality pictures 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.
In accordance with Ramanujam, current standard practices for cervical cancer screenings 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 expert to administer the test. As an outcome, she notes that cervical cancer is more prevalent in females living in low socioeconomic communities that do not have access to these resources.
“The mortality rate of cervical cancer should absolutely be 0% because we have all the tools to see and treat it—but, it is not,” claims Ramanujam. “That is in part because women don’t get screening or do not follow up on a positive screening to have colposcopy performed at a referral clinic. We require bringing colposcopy to women so that we can decrease this complicated string of actions."
The device, which was established 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 involves 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 screenings procedure.
Researchers are working on automating the screening procedure by utilizing image processing and machine learning to teach computers how to spot signs of precancerous and cancerous cells. Finally, Ramanujam considers women could use the device to self-screen, eliminating the requirement for a trained physician, and hence 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 complications in getting females screened for cervical cancer in the developing country due to the uncomfortable speculums.
“Cervical cancer screenings commonly needs use of a speculum to give a clear view of the cervix. The speculum is one potential barrier to screening because of fear of pain, discomfort and embarrassment,” write Ramanujam and her coworkers in a May 31 article in the journal PLOS One. “This research indicates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of females with potential for synergistic HPV and Pap smear sample collection.”
In their research of 15 volunteers at Duke, with self-insertion and physician-assisted cervix image capture, adequate cervix visualization for 83% of sufferers was demonstrated, while 92.3% 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 sufferers enrolled to date. New researches are planned in Honduras and Zambia. The speculum-free version has been recently launched 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 have applied for extra funding from the NIH to continue these efforts,” Ramanujam summarizes, while noting that the team is working on regulatory clearance for the device, which they hope to get by the end of 2017.
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