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

Study Overview
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Brief Summary
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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.

Detailed Description
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This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah). 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. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases. 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.

Official Title
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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

Conditions
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Cervical Precancer

Intervention / Treatment
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* Procedure: Thermocoagulation (device)
* Procedure: Cryotherapy (device)
* Procedure: LEEP (device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive on VIA test for cervical cancer screening Eligible for ablative treatment Exclusion Criteria: Pregnancy Not voluntarily willing to participate

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermocoagulation (device)<br>VIA Positive women will be treated by the new device for thermocoagulation | Procedure: Thermocoagulation (device)<br>* Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix<br>|
| Active Comparator: Cryotherapy (device)<br>VIA positive women will be treated by cryotherapy | Procedure: Cryotherapy (device)<br>* Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix<br>|
| Active Comparator: LEEP (device)<br>VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP | Procedure: LEEP (device)<br>* The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens | The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical precancer, screening, treatment, thermo-coagulation, thermal ablation, Reducing overtreatment