Randomized controlled trial (RCT) of the Liger Thermal Coagulator versus cryocautery and versus large loop excision of the transformation zone (LLETZ) to prevent cervical neoplasia in VIA-positive women in LMICs (the DELTA study)

Study sites:	Lusaka, Zambia
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	G. Parham, Cervical Cancer Prevention Program, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia Walter Prendiville, International Federation of Cervical Pathology and Colposcopy, Frederick MD, USA
Map:
Start date:	2016
Closure date:	Ongoing
Objectives:	To develop and evaluate a cordless, lightweight, rechargeable, hand-held thermal coagulator for the treatment of cervical precancerous lesions in low- and middle-income countries (LMICs) and, if the device is validated, to make it available at an affordable price specifically for LMICs To evaluate a safe method for reducing overtreatment of visual inspection with acetic acid (VIA)–positive women using the ZedScan biophysical device The study design contains two phases: an exploratory UH2 phase and a randomized controlled trial UH3 phase.
Methodology:
ClinicalTrials.gov identifier:	NCT02956239
Publications:	Pinder L.F., Parham G.P., Basu P., Muwonge R., Lucas E., Nyambe N., Sauvaget C., Mwanahamuntu M.H., Sankaranarayanan R., Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2019 Nov 13. pii: S1470-2045(19)30635-7. PMID: 31734069
Funding:	United States National Institutes of Health (NIH)
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