Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

VIA Positive women will be treated by the new device for thermocoagulation

VIA positive women will be treated by cryotherapy

VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP

Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix

Thermocoagulation (device)

Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix

Cryotherapy (device)

The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit

LEEP (device)

Partha Basu, Dr

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.

This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are

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.

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

The VIA positive women will be followed up after 12 months to see if the lesions have disappeared. HPV test will be used as the test of cure

The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT02956239	Cervical Precan...	Thermocoagulati... Cryotherapy (de... LEEP (device)	25 Years - 49 Years	International Agency for Research on Cancer
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	NCT02956239	Cervical Precan...	Thermocoagulati... Cryotherapy (de... LEEP (device)	25 Years - 49 Years	International Agency for Research on Cancer

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