Safety and Efficacy of the New CryoPop® Cryotherapy Device for Cervical Dysplasia in Low- and Middle-income Countries: Study Protocol for a Multicentre Open-label Non-inferiority Clinical Trial With Historical Controls

Abstract Background: Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions. Methods: This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers and potential participants. Organized community based as well as hospital-based screening is being conducted using Visual Inspection with Acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device.Discussion: There is a need to develop an inexpensive, simple and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment.Trial Registration: Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644 on November 6, 2019. https://bit.ly/3yRQWC4