{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:31:14Z","timestamp":1789648274828,"version":"4.0.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T00:00:00Z","timestamp":1719273600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T00:00:00Z","timestamp":1719273600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"National Institute of Health (NIH\/NCI), USA"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Nat Med"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 (<jats:italic>P<\/jats:italic>\u2009=\u20090.83). 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.<\/jats:p><jats:p>ClinicalTrials.gov registration: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT02956239\">NCT02956239<\/jats:ext-link>.<\/jats:p>","DOI":"10.1038\/s41591-024-03080-w","type":"journal-article","created":{"date-parts":[[2024,6,25]],"date-time":"2024-06-25T10:07:29Z","timestamp":1719310049000},"page":"2596-2604","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial"],"prefix":"10.1038","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0124-4050","authenticated-orcid":false,"given":"Partha","family":"Basu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mulindi","family":"Mwanahamuntu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leeya F.","family":"Pinder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Muwonge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1252-1925","authenticated-orcid":false,"given":"Eric","family":"Lucas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namakau","family":"Nyambe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samson","family":"Chisele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron Lunda","family":"Shibemba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Sauvaget","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rengaswamy","family":"Sankaranarayanan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Prendiville","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Groesbeck P.","family":"Parham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,25]]},"reference":[{"key":"3080_CR1","unstructured":"WHO Guideline for Screening and Treatment of Cervical Pre-cancer Lesions for Cervical Cancer Prevention 2nd edn (World Health Organization, 2021)."},{"key":"3080_CR2","unstructured":"Comprehensive Cervical Cancer Control: A Guide to Essential Practice 2nd edn (World Health Organization, 2014)."},{"key":"3080_CR3","unstructured":"WHO Guidelines for the Use of Thermal Ablation for Cervical Pre-cancer Lesions (World Health Organization, 2019)."},{"key":"3080_CR4","unstructured":"Prendiville, W. et al. Colposcopy and Treatment of Cervical Precancer. IARC Technical Publication No. 45 (IARC, 2017)."},{"key":"3080_CR5","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1097\/AOG.0b013e318254f90c","volume":"120","author":"J Bornstein","year":"2012","unstructured":"Bornstein, J. et al. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet. Gynecol. 120, 166\u2013172 (2012).","journal-title":"Obstet. Gynecol."},{"key":"3080_CR6","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1002\/ijgo.12185","volume":"138","author":"F Holme","year":"2017","unstructured":"Holme, F. et al. Scaling up proven innovative cervical cancer screening strategies: challenges and opportunities in implementation at the population level in low- and lower-middle-income countries. Int. J. Gynaecol. Obstet. 138, 63\u201368 (2017).","journal-title":"Int. J. Gynaecol. Obstet."},{"key":"3080_CR7","unstructured":"Ameyan, L. et al. 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The other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}