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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|