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

Cervical Precancer Clinical Trial

— DELTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956239
• Other study ID #: 1UH2CA202721-01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2024
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3124
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

Inclusion Criteria:

• Positive on VIA test for cervical cancer screening

• Eligible for ablative treatment

Exclusion Criteria:

• Pregnancy

• Not voluntarily willing to participate

Related Conditions & MeSH terms

• Cervical Precancer
• Uterine Cervical Dysplasia

Intervention

Procedure:
• Thermocoagulation (device)
Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
• Cryotherapy (device)
Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
• LEEP (device)
The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit

Locations

Country	Name	City	State
Zambia	UNC Global Project Zambia	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Liger Medical Llc, University of North Carolina Global Project Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (2)

Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31. — View Citation

Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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