How the POCkeT Colposcope addresses issues related to cervical cancer
Updated: Sep 5, 2019
How the POCkeT Colposcope addresses issues related to cervical cancer care in LMICs and Ways in which the device can be improved
WHO guidelines for cervical cancer screening in low resource settings outline a see-and-treat approach which involves visual inspection of the cervix after application of acetic acid or lugol’s Iodine. Some obstacles to this approach in low resource settings include lack of early screening tools, missed diagnoses and over-treatment due to lack of technology. Most health clinics in low resource settings perform visual inspection of the cervix with the naked eye which requires the presence of trained health workers and leads to high rates of misdiagnoses. Colposcopes which are used to capture images of the cervix after acetic acid or Lugol’s Iodine application for further assessment to improve accuracy in screening are very expensive and can range from $5000-$20000. The Point-of-Care Tampon (POCkeT) Colposcope is a low-cost alternative to the colposcope, enabling transvaginal colposcopy of the cervix. It addresses several issues associated with cervical cancer screening in LMICs as outlined below.
The low capital cost (approximately $500) of the POCkeT colposcope paired with the high image quality makes it more accessible to healthcare providers in LMICs. The POCkeT colposcope has been demonstrated via an image concordance study involving seven doctors from five different countries to be equivalent to the more expensive, high end digital colposcopes in terms of image quality. Hence it can fit neatly into the see-and-treat paradigm and add great value to the existing healthcare infrastructure for cervical cancer screening.
It’s highly-portable design allows it to be easily transported around the community to conduct screening. This proffers the dual benefit of being able to bring the device to areas that do not have a high density of healthcare facilities, and of shifting the task of colposcopy for screening from a clinical setting to a community setting.
The POCkeT colposcope, unlike existing standard-of-care colposcopes, does not require highly trained colopscopists to operate it and can potentially be used by a healthcare worker. The photos procured can be sent to a specialist for further analysis, since the POCkeT colposcope can connect to a smartphone. Given that many LMICs have low physician densities particularly in rural areas, the practical impact of this task-shifting is considerable.
In some regions in LMICs, power supply is intermittent. Existing gold-standard colposcopes are not able to operate without power from a wall socket, precluding the possibility of screening when power is unavailable. In contrast, the POCkeT colposcope uses the power source of the connecting device (phone, tablet or laptop) all of which use rechargeable batteries and hence can last up to 8 hours in the event of a power outtage.
There exist cultural and educational barriers to cervical cancer screening, relating to the process being a genital examination . While technology alone is not able to address such factors, the speculum-free operation capability of the POCkeT colposcope could play a part in paving the way to break down such barriers by first making the colposcopy procedure more comfortable for the patient. There are several obstacles to care in LMICs that may at first seem like minutiae, but which could in practice be significant impediments to care. For example, sterilization equipment is not readily available in rural areas of many LMICs and this could thwart the use and re-use of biomedical devices. However, the POCkeT colposcope has been developed as a waterproof device, which allows it to be sterilized through soaking in bleach. Since bleach is available in most areas, the issue of sterilization was side- stepped. Several other such challenges might surface as the POCkeT colposcope nears implementation; and the ability to make adaptations as necessary to respond to these will determine the ultimate efficacy and impact of the device.
Suggested improvements to current design
User friendly design: The current design has buttons that signal green light, white light, and photo capture. The question that follows is --will all health practitioners receive the proper training to handle the device? Is operating the device an intuitive process? There could be some room to add small icons near the buttons to allow for easy to understand, user-friendly design that would not require a manual. Additionally, the user interface should be made easy and intuitive to use by health workers.
Speculum free mechanism and Patient comfort: In addition to use by clinicians, the development of a vaginal inserter for speculum-free cervix imaging is another area of interest. The need for speculums in cervical exams is a deterrent to many women for fear of pain, physical discomfort, anxiety, or feelings of embarrassment and vulnerability. Since the POCkeT was modeled after the tampon, a hollow plastic applicator would allow women to insert the device through the thin tube and image their cervix themselves, in privacy at a physician’s office or even in the comfort of their home. The inserter could also provide a disposable sanitary barrier between the device and the vaginal tissue.
Preliminary data from patient use in multiple clinics demonstrates increased comfort and a better overall screening experience with the POCkeT compared to speculum-based exams. This model should reduce the fear and discomfort associated with a speculum, in addition to empowering women to take ownership over their own health. However, a self-exam may be difficult if the cervix is not oriented in an easily accessible position. Even in these cases when a clinician must image the cervix, the applicator can be implemented to reduce pain and vulnerability in the same way. An applicator-based, speculum-free delivery mechanism would provide the very best in patient-centered design. Improvements in the design should be identified from patient feedback, but one consideration is to construct a second tube to allow the physician to visualize the cervix during treatment. Currently, the inserter pushes on the internal walls to allow the health practitioner to view the cervix. However, if other procedures are to be performed in the continuum of care such as treatment, how is the health practitioner to have a field of view while performing other tasks? There could be potential to improve upon the design to better support other tasks within the new “see and treat” paradigm. It is important to think about how the POCkeT colposcope can be integrated into the current care regimen.
Mobile Health and Automated Diagnoses
A mobile health addition to the POCkeT Colposcope will allow for storage and easy identification of patient data, provide ability to transfer images to remote physicians for expert diagnosis and serve as a training tool. Additionally, automated diagnoses could be added to enable immediate, real time diagnosis of the images and will reduce the need for trained colposcopists and enable feasibility of community health screening.
See-and-treat: The POCkeT Colposcope should increase access to cervical cancer screening and the diagnosis of cervical cancer in the early, more treatable stages. But once diagnosed with our device, what options do women have for treatment? Since the POCkeT has been designed to address the “see” in the see-and-treat paradigm, a same-day treatment option must also be developed. Currently, the most widely available treatment in LMICs is cryotherapy, where abnormal areas on the cervix can be are frozen using a metal probe chilled with freezing gas. The cancerous cells are then shed over the course of a few weeks. This treatment is typically paired with a visual inspection by a doctor three to six months following treatment. However, the limited supply and high cost of gas in some areas, coupled with the low portability of the large tanks, limits access to this treatment. Even where cryotherapy is available, the penetration depth is very shallow and deeper cancerous cells may not be fully removed. An alternative treatment, ethanol therapy, has been developed for treatment of other cancerous lesions and will likely prove efficacious in cervical cancer treatment. In this procedure, a mixture of pure ethanol and ethyl cellulose is injected locally to ablate the tumor. The ethyl cellulose is added to form a gel that keeps the ethanol in the target zone without leaking out of the tumor and harming the surrounding healthy tissues. Of course, problems persist with this ethanol therapy, including the need to develop a controlled release of the ethanol mixture and ensuring proper dosing to avoid intoxicating the patient. In practice, treatment by ethanol may require specific training of medical professionals, but likely no more than for other treatments like cryotherapy.
 Agurto, Irene, et al. "Perceived barriers and benefits to cervical cancer screening in Latin America." Preventive medicine 39.1 (2004): 91-98.