CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Setting

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DESCRIPTION (provided by applicant): Cervical cancer is a leading cause of mortality in low and middle-income countries (LMICs). In order to address this problem, the World Health Organization has recently released guidelines that endorse HPV based screening and visual inspection with acetic acid (VIA). These guidelines will facilitate increased screening coverage and detection of cervical "precancer", a curable precursor to cervical cancer. However, screening must be linked to timely and adequate treatment in order to decrease mortality. The current treatment standard, nitrous oxide (N2O) based cryotherapy, has failed to adequately address the problem as it is expensive, difficult to procure, and hard to transport. The purpose of this application is to transform a non-gas based ablative device, the CryoPen(R) Cryosurgical System, into an inexpensive and easily transportable cryotherapy device, specifically for use in LMICs that can be used by any level of health care provider. The Specific Aims of this project are to 1. Develop an LMIC-adapted CryoPen(R) Cryosurgical System that is optimized for use in LMICs. 2. Show that the LMIC-adapted CryoPen(R) has clinical potential. 3. Demonstrate that the cure rate of CryoPen(R) is non-inferior to N2O-based cryotherapy for the treatment of cervical precancer. 4. To create a comprehensive model for the deployment and use of the LMIC-adapted CryoPen(R). Development of a transportable, reliable, and inexpensive device will change the cervical cancer prevention paradigm from a "see and refer" strategy to an integrated true "see and treat" field approach. The action steps that will be taken to modify the current CryoPen(R) to an LMIC-adapted version are: ensuring clinical potential by performing a non-inferiority depth of necrosis test and then completing a clinical trial with cost effectiveness analysis. The expected results are the development of a treatment that is non-inferior, more cost-effective, and better suited to the LIMC setting than N2O-based cryotherapy. Our research team has well established relationships with leading regional organizations that provide guidance to government run cervical cancer prevention programs. Introduction of the CryoPen(R) to these already existing programs will not only improve program efficacy, but will also serve as a model for adoption of the technology in the region. The results of this study will affect other research areas by serving as a springboard to explore treatment alternatives that can be used globally in LMICs and thus reach the most vulnerable populations.