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)

International Agency for Research on Cancer

Status: Completed

Conditions: Cervical Precancer

Treatments: Procedure: Cryotherapy (device); Procedure: LEEP (device); Procedure: Thermocoagulation (device)

Study type: Interventional

Funder types: Other

Identifiers

NCT02956239

1UH2CA202721-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,124 patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive on VIA test for cervical cancer screening
• Eligible for ablative treatment

Exclusion criteria

• Pregnancy
• Not voluntarily willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,124 participants in 3 patient groups

Thermocoagulation (device)

Experimental group

Description:

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

Treatment:

Procedure: Thermocoagulation (device)

Cryotherapy (device)

Active Comparator group

Description:

VIA positive women will be treated by cryotherapy

Treatment:

Procedure: Cryotherapy (device)

LEEP (device)

Active Comparator group

Description:

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

Treatment:

Procedure: LEEP (device)