Safety and efficacy of the new CryoPop® cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls

S Yogeshkumar, Jean Anderson, Enriquito Lu, Edward Kenyi, Margaret Mensa, Katrina Thaler, Ramalingappa Antartani, Kasturi Donimath, Basavaraj Patil, Santosh Chikaraddi, Shailaja Bidri, Aruna Biradar, Muttappa R Gudadinni, Laxmikant Lokare, Gayane Yenokyan, Mrutyunjaya B Bellad, Shivaprasad S Goudar, Richard Derman, Amit Revankar, Hema Patil, Ramadevi Wani, Ranjit Kangle, Ramesh Y Chavan, Mahantesh B Nagmoti, Yogendra M Kabadi, Purushotham Reddy, Sunita Vernekar, Surekha Hipparagi, Vijayalaxmi Patil, Anita Dalal, S Yogeshkumar, Jean Anderson, Enriquito Lu, Edward Kenyi, Margaret Mensa, Katrina Thaler, Ramalingappa Antartani, Kasturi Donimath, Basavaraj Patil, Santosh Chikaraddi, Shailaja Bidri, Aruna Biradar, Muttappa R Gudadinni, Laxmikant Lokare, Gayane Yenokyan, Mrutyunjaya B Bellad, Shivaprasad S Goudar, Richard Derman, Amit Revankar, Hema Patil, Ramadevi Wani, Ranjit Kangle, Ramesh Y Chavan, Mahantesh B Nagmoti, Yogendra M Kabadi, Purushotham Reddy, Sunita Vernekar, Surekha Hipparagi, Vijayalaxmi Patil, Anita Dalal

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 . Registered on November 6, 2019.

Keywords: Cervical dysplasia; CryoPop®; Cryotherapy; Low- and middle-income countries.

Conflict of interest statement

The authors declared no conflict of interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
CryoPop® Device (Pregna. Accessed 15 April 2021 https://tinyurl.com/yzrpqwrh)
Fig. 2
Fig. 2
CryoPop® study schedule of enrollment, intervention, and assessments
Fig. 3
Fig. 3
CryoPop® study schedule of case report forms by visits

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