Clinical trial · Interventional
Development, Field Testing and Evaluation of the Efficacy of a Hand-held, Portable and Affordable Thermo-coagulator to Prevent Cervical Cancer in Low- and Middle-income Countries
NCT02956239CI-TRIAL-00078607DELTAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Precancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy (device) | Procedure | — | UNRESOLVED |
| LEEP (device) | Procedure | — | UNRESOLVED |
| Thermocoagulation (device) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Thermocoagulation (device)
- description
- VIA Positive women will be treated by the new device for thermocoagulation
- interventionNames
- Procedure: Thermocoagulation (device)
- type
- ACTIVE_COMPARATOR
- label
- Cryotherapy (device)
- description
- VIA positive women will be treated by cryotherapy
- interventionNames
- Procedure: Cryotherapy (device)
- type
- ACTIVE_COMPARATOR
- label
- LEEP (device)
- description
- VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Positive on VIA test for cervical cancer screening * Eligible for ablative treatment Exclusion Criteria: * Pregnancy * Not voluntarily willing to participate
References
Publications (3)
- BACKGROUNDPinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, 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. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14. PMID 31734069
- BACKGROUNDMwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31. PMID 34197624
- BACKGROUNDBasu P, Mwanahamuntu M, Pinder LF, Muwonge R, Lucas E, Nyambe N, Chisele S, Shibemba AL, Sauvaget C, Sankaranarayanan R, Prendiville W, Parham GP. A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial. Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25. PMID 38918630