Journal Article

A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial

Mwanahamuntu, Mulindi, Prendiville, Walter, Lucas, Eric, Sauvaget, Catherine, Sankaranarayanan, Rengaswamy, Basu, Partha, Shibemba, Aaron Lunda, Chisele, Samson, Nyambe, Namakau, Pinder, Leeya F., Muwonge, Richard, Parham, Groesbeck P.

2024

Overview

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority ( P  = 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision. ClinicalTrials.gov registration: NCT02956239 . A randomized controlled trial performed in a screen-and-treat program in Zambia found that a portable, battery-operated thermal ablation device was not inferior to cryotherapy and electrosurgical excision in cervical precancer treatment.

• Publisher: Nature Publishing Group US,Nature Publishing Group
• Subject: 692/308 / 692/308/2779 / Ablation / Ablation Techniques - instrumentation / Ablation Techniques - methods / Access control / Acetic acid / Adult / Biomedical and Life Sciences / Biomedicine / Cancer Research / Cervical cancer / Clinical trials / Cryotherapy / Cryotherapy - instrumentation / Cryotherapy - methods / Early Detection of Cancer - methods / Effectiveness / Electrosurgery - instrumentation / Electrosurgery - methods / Female / Heat treatment / Human papillomavirus / Humans / Infectious Diseases / Inspection / Metabolic Diseases / Middle Aged / Molecular Medicine / Neurosciences / Papillomaviridae - isolation & purification / Papillomavirus Infections / Portable equipment / Thermal transformations / Treatment Outcome / Uterine Cervical Dysplasia - surgery / Uterine Cervical Dysplasia - virology / Uterine Cervical Neoplasms - surgery / Uterine Cervical Neoplasms - virology / Zambia