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 (DELTA)
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|ClinicalTrials.gov Identifier: NCT02956239|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cervical Precancer||Procedure: Thermocoagulation (device) Procedure: Cryotherapy (device) Procedure: LEEP (device)||Not Applicable|
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 will be developed and tested in vitro and in vivo. 200+ Liger units will be produced and a randomised controlled trial of the device will be undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy will allow 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||February 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2021|
Experimental: Thermocoagulation (device)
VIA Positive women will be treated by the new device for thermocoagulation
Procedure: Thermocoagulation (device)
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: Cryotherapy (device)
VIA positive women will be treated by cryotherapy
Procedure: Cryotherapy (device)
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: LEEP (device)
VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP
Procedure: LEEP (device)
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit
- Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline [ Time Frame: 12 months ]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
- Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens [ Time Frame: 12 months ]The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956239
|Contact: Rengaswamy Sankaranarayanan, Dr||0472738485 ext 8674||SankarR@iarc.fr|
|Contact: Partha Basu, Dr||0472738485 ext 8674||BasuP@iarc.fr|
|Principal Investigator:||Rengaswamy Sankaranarayanan||IARC|