CryoPop, Jhpiego’s innovative cryotherapy device to treat cervical lesions more easily and at lower cost, is being produced by Pregna International Ltd, an Indian manufacturer known mainly for intrauterine contraceptive devices (IUDs). The agreement with Pregna focuses on both commercial and research uses of the handheld device, which converts carbon dioxide to dry ice to freeze and destroy precancerous lesions.
CryoPop was developed through a collaboration between Jhpiego and the Johns Hopkins Center for Bioengineering Innovation and Design (CBID) and three biomedical engineering students—Shuja Dawood, John Sidhom and Marton Varady. CryoPop’s modular design and efficient use of carbon dioxide, in cylinders similar to those used in soda machines, could help bring the single visit approach for cervical cancer prevention to even the most remote areas.
The World Health Organization recommends cryotherapy as secondary prevention of cervical cancer. Though highly effective, standard cryotherapy treatment requires a refrigerant gas, which typically comes in large, heavy cylinders that are expensive and must be tethered to the cryotherapy device. CryoPop offers a more mobile, cost-effective and robust alternative to reach women in low-resource settings, especially in rural, low-resource regions.
Jhpiego recently sat down with Margaret Mensa, Clinical Research Program Manager of the CryoPop project at Jhpiego and a nurse, and Dr. Jean Anderson, Director of the Johns Hopkins HIV Women’s Health Program and Professor of Gynecology and Obstetrics, and Principal Investigator on the CryoPop project, for an update on the device’s testing and manufacture.
Can you update us on CryoPop?
From the labs at Johns Hopkins, where CryoPop was developed, the project moved into a study phase. In the first test of CryoPop in humans, the study sought to assess CryoPop’s performance in women who had normal Pap smears and had planned hysterectomy 24–48 hours after the procedure. This part of the study, which took place in the Philippines, is complete. It found that CryoPop is comparable to other cryotherapy devices in terms of its ability to freeze the cervix appropriately.
The second part of the study, which begins in April 2020, will focus on effectiveness in actually treating women with precancerous cervical lesions, as well as safety. We’ll test CryoPop in women who have biopsy-proven, high-grade cervical dysplasia (precancerous lesions) and are eligible for cryotherapy. We plan to recruit 100 women, treat them with CryoPop and then follow them for 6 months. Our goal is to prove that CryoPop is equally effective to standard devices.
One of the challenges in this type of study is that women aren’t routinely screened for cervical cancer in most low-resource settings. Since we need to screen a large pool of women to find 100 with high-grade cervical lesions, we needed to find an alternate site. We’re collaborating with a group at the Jawaharlal Nehru Medical College in Belgaum, India, that has a long history of National Institutes of Health-funded research, mostly in maternal and child health.
Is the device currently on the market?
Yes. Pregna has obtained the appropriate approvals and registrations in India. It is manufacturing the device for the study as well as for commercial sale. Because the study is continuing, the device can be commercialized without additional data. However, we feel that it’s important to now prove that it’s comparable to standard devices in treatment of precancerous cervical lesions.
How will CryoPop improve treatment of cervical cancer?
It provides another tool to prevent cervical cancer—one that’s particularly relevant to low-resource areas. CryoPop is less expensive (about 15% of the cost of standard devices); it has a simpler design and is more durable under harsh working conditions; and it’s about 10 times more efficient in its use of carbon dioxide than standard devices. We think it may be particularly useful in mobile settings.
How does CryoPop compare to other methods, such as thermal coagulation?
We don’t know yet. They’re totally different procedures, of course. One uses cold, the other heat. Standard cryotherapy devices are about 95% effective in eliminating high-grade lesions. We hope to prove that CryoPop is not inferior to those devices. Thermal coagulation is being used now more than it was, and we still don’t have a lot of head-to-head comparisons with cryotherapy. But for low-resource countries, having more alternatives is a good thing—assuming they’re all effective.
Margaret, how has your training as a nurse informed your work managing the CryoPop program?
Clinical research is highly regulated to ensure the safety and wellbeing of study participants. It is also an essential tool to help improve treatment and the quality of care for patients. By training, nurses act as patient advocates. In the clinical setting as in research, nurses help patients and participants make informed ethical decisions regarding their care. In my role as research program manager, participant safety, protection and wellbeing throughout the study remain paramount in the management and implementation of the protocol with multidisciplinary and diverse teams.
In this International Year of the Nurse and the Midwife, Jhpiego celebrates innovations that not only save lives, improve health and transform futures, but also empower nurses and midwives, the frontline workers who provide the majority of patient care. Jhpiego’s comprehensive strategy for cervical cancer prevention puts nurses and midwives at the forefront, educating and providing HPV vaccination, self-testing for HPV and screening and treatment of precancerous lesions. CryoPop provides a new tool for reaching the most vulnerable with these vital cancer prevention services.