Novel device aims to make cervical cancer screening more accessible
Future directions
Efforts are underway to further improve the design for better visualization, ease of use, and comfort. The next phase of study will involve comparing visualization between the device and a standard speculum for routine exams and more advanced cancer screening exams. Ms. Asiedu said the researchers are also seeking to modify the inserter to accommodate the original Pocket Colposcope with a 5-megapixel camera for better image quality.
Should the inserter and colposcope be validated in further studies, the potential benefits are numerous, she said, explaining that the device’s potential for expanding access to screening are driven by its portability and low cost; the 2-megapixel camera currently used with the device costs about $54, compared with $20,000 for a standard-of-care digital colposcope. The estimated cost of the inserter under mass production would be less than $1.
It may be possible to produce the inserter in varying sizes to match cervix size. There are other potential uses for the device, including at-home viewing of the cervical os to gauge cervical dilation during labor and to detect false labor, she and her colleagues noted.
One limitation, which is also a problem with current methods of visual inspection of the cervix, is lack of ability to see the squamocolumnar junction.
“It is therefore not a replacement for gold standard pathology, where cells from the squamocolumnar junction are removed for pathology. However, our device can aid in guiding biopsies and has merit for places that lack gold standard biopsy,” they wrote, noting that future studies will compare cervix samples collected via the inserter versus a standard speculum to explore the possibility of self-sampling.
Efforts also are underway to develop an algorithm for making a diagnosis based on such samples, Ms. Asiedu said.
Given that 11 of the 15 volunteers in the study said that self-screening with the device was more difficult than having a physician perform the exam, another longitudinal study will look at whether ease of use improves over time, she said.
“There’s a lot of work to be done to get it where it could be routinely used,” Dr. Schmitt said. “Even for someone like me who does have this healthy skepticism, this might really be a profound change in the way we do pelvic exams.”
A word of caution
But Michael R. Caudle, MD, an ob.gyn. with Cherokee Health Systems in Knoxville, Tenn., urged caution, at least among rural U.S. health centers, with any approach that involves only visualizing the cervix. His concern is that this type of device could give women “false reassurances.”
“The promulgation of Pap smears and HPV testing would be the direction rural sites should go,” he said. “Colposcopy requires biopsies to rule out serious disease.”
He noted that the American Society for Colposcopy and Cervical Pathology (ASCCP) provides training for mid-level providers to do these evaluations.
“I think this is better than looking only. We see tragedies from women not getting adequate follow-up for abnormal paps, so making this even more removed from proper oversight is a concern. There have been attempts in the past to send photos of the cervix for evaluation and one problem again was the lack of biopsies.
“Rural health departments do a good job at triaging abnormal paps, and expansion of this, in my opinion, is a better idea,” he said.
The Duke University study was supported by the National Institutes of Health. Ms. Asiedu reported having no disclosures, but two of her coauthors founded companies and developed technologies related to this work where the investigators or Duke may benefit financially if the system is sold commercially. Ms. Asiedu and her coauthors have filed a provisional patent application for the concept of the system.
