Development of Alternative Ablation Device

Development of Alternative Ablation Device for Cervical Pre-Cancer Treatment

The trial aims to demonstrate that the cure rates of the CryoPen® and the thermoablator are non-inferior to the cure rate of CO2-based cryotherapy; determine patient acceptability of each therapy type by actively assessing side effects and monitoring pain levels related to treatment; evaluate screening methods one-year post-ablation by comparing the sensitivity of low-cost HPV screening tests, HPV DNA genotyping tests, cytology, and biopsies. 

Lay Abstract

In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of cervical cancer. A strategy for achieving this goal was ratified by member states in August 2020. The WHO plan calls for an aggressive approach of vaccination against the human papillomavirus (HPV), the single cause of cervical cancer, and screening and treatment of precancerous lesions caused by HPV infections before they progress to invasive disease. In low- and middle-income countries (LMIC), which bear 90% of cervical cancer incidence globally, it is estimated that these goals will not be reached until 2120 – a century from now. One way to markedly shorten this timeline is to provide widespread high-performance testing for cervical precancer followed by immediate treatment of any abnormalities. Currently, the most commonly used method of treatment of pre-cancer is using gas-based cryotherapy. Although gas-based therapy is effective, it is difficult to have widespread scale-up because gas tanks are heavy and difficult to transport, tanks need to be refilled and equipment requires maintenance to function properly. The purpose of this study is to examine alternatives to gas-based cryotherapy including non-gas-based cryotherapy (funded by NIH) and thermal ablation (funded by rising tide). This is a randomized controlled trial which will compare cure rates of high-grade cervical precancer after treatment with cryotherapy and the 2 alternative approaches. Upon successful completion of this trial low-cost, portable, effective treatment for cervical pre-cancer will be clinically validated. Clinically validated tools for treatment of pre-cancer are crucial for worldwide elimination.