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
NCT ID: NCT02956239
Last Updated: 2024-07-08
Study Results
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Basic Information
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COMPLETED
NA
3124 participants
INTERVENTIONAL
2017-08-01
2024-02-29
Brief Summary
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Detailed Description
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1. To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah).
2. To evaluate the success / failure rate of Thermal Coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to Large Loop Excision of the Transformation Zone (LLETZ aka LEEP) as part of a screen and treat programme in Zambia.
3. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia.
4. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases.
5. To determine the value of Z scan to predict normality and abnormality in VIA positive women randomly assigned to excisional therapy
In collaboration with a medical devices company in Utah, the engineering performance of the Liger Thermal Coagulator has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thermocoagulation (device)
VIA Positive women will be treated by the new device for thermocoagulation
Thermocoagulation (device)
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Cryotherapy (device)
VIA positive women will be treated by cryotherapy
Cryotherapy (device)
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
LEEP (device)
VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP
LEEP (device)
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit
Interventions
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Thermocoagulation (device)
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Cryotherapy (device)
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
LEEP (device)
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit
Eligibility Criteria
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Inclusion Criteria
* Eligible for ablative treatment
Exclusion Criteria
* Not voluntarily willing to participate
25 Years
49 Years
FEMALE
No
Sponsors
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University of North Carolina Global Project Zambia
UNKNOWN
Liger Medical Llc
UNKNOWN
International Agency for Research on Cancer
OTHER
Responsible Party
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Partha Basu
Early Detection, Prevention and Infection Branch at IARC, WHO
Principal Investigators
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Partha Basu, Dr
Role: PRINCIPAL_INVESTIGATOR
IARC
Locations
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UNC Global Project Zambia
Lusaka, , Zambia
Countries
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References
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Pinder 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.
Mwanahamuntu 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.
Basu 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.
Other Identifiers
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