A device small enough to fit in a pocket has the potential to revolutionize how cervical cancer is screened across the globe.

Nimmi Ramanujam, Robert W. Carr Jr. professor of biomedical engineering, and her team of researchers from the Pratt School of Engineering have designed a device aimed at making cervical cancer screening more accessible and affordable. This point-of-care tampon ("pocket") colposcope provides a solution to the many challenges of screening in low and middle-income countries.

"While cervical cancer mortality is on the decline in the United States and developed countries, it's actually on the rise in lower resource settings," said Marlee Kreiger, research program manager in the Ramanujam lab. "What we've done to address this disparity is we've created the 'pocket' colposcope, which as the name suggests, means the device can fit in the pocket of a physician or a healthcare worker, enabling them to take the device anywhere to screen a woman."

In many developed countries, increased public education efforts as well as the use of the Pap smear has made cervical cancer easier to identify and treat. However, many low and middle-income countries have not shared similar progress. In fact, the World Health Organization estimates that as much as 88 percent of cervical cancer-attributed deaths occur in those countries.

One key feature of this "pocket" design is its reasonable price, Krieger explained. Although traditional colposcopes range from $5,000 to $20,000 in price, the Ramanujam lab's invention costs no more than a few hundred dollars.

Krieger added that this device also requires significantly less training to operate than a traditional colposcope, meaning that the act of capturing images of the cervical region can potentially be performed by midwives, nurses or even patients themselves. The camera can also be attached to any USB-capable device, such as a mobile phone or laptop, which presents the opportunity to save and send images collected by healthcare professionals to be examined later by more experienced physicians.

Dr. John Schmitt, director of Duke's Cervical Cancer Prevention Clinic and professor of obstetrics and gynecology, noted the possibility of uploading medical images from the device to the cloud, where they could then be examined by experts and used to teach diagnostics. Schmitt noted that having these images examined by professionals could help improve the outcomes of cervical cancer patients either by allowing them to get treatment at the earliest disease stages.

"The future holds some really good screening technique where you can identify cancer precursors that are very easy to treat and don’t affect fertility and don't affect mortality," he said. "The vision right now is that you can eventually screen women very easily."

Schmitt is among a group of medical experts who have been working to implement the device across Peru, Tanzania, Zambia and India. They hope to eventually transition the practice of cervical cancer screenings closer to where women live rather than requiring them to travel miles for an exam.

The design of the inserter used with the colposcope may also provide relief for many women who are weary of the original colposcope. In the Ramanujam lab's design, the inserter acts as a replacement for the traditional speculum, a device which is designed to spread the vaginal walls and make the cervix visible for examination. For many women, the speculum serves as an embarrassing barrier for cervical cancer screening, causing pain and discomfort.

"Through the inserter, we hope that cervical cancer screening will be more comfortable and thus more women would be encouraged to get screened," said Júlia Sroda Agudogo, Pratt '17, who helped to develop the device as an undergraduate. "Additionally, the promise of the inserter to be used for self-colposcopy would be critical in more conservative settings in which women are deterred from screening due to the stigma associated with screening by a male physician."

In a pilot clinical study conducted by the Duke group, 100 percent of participants deemed the inserter used with the "pocket" colposcope to be more comfortable than the traditional speculum. Reactions on a greater scale have also been promising, Schmitt noted.

"The response has been amazing," he said. "I've had several people just say, 'well, can we just stop using what we're using'—which typically is either a cell phone or a handled 35 mm camera to record images—'and use this?'"

Although the device has plenty of potential, obstacles remain before it may replace current standard-of-care screening procedures, Schmitt said. The process of implementing the device has been greatly slowed by regulatory entities in the countries whose citizens need the device most.

Given these regulatory hurdles, the "pocket" colposcope has still not yet been implemented in its entirety across the globe.

Krieger said the device’s potential ability to influence medicine will most profoundly require policy change in the countries that can benefit from its implementation. Because of this, the team says they are tasked with much more than simply developing a new screening device.

"You can't just make novel technologies for low-resource settings," Krieger said. "You really have to design a technology around the human that's going to use them and around the environment they're going to be used in."