Thermal Ablation Study

Primary Sponsor Details

Secondary Sponsor Details

Zimbabwe 

Clinically healthy women aged 25-59 years, not pregnant, (a pregnancy test will be carried out) with an intact uterus and with no history of debilitating physical and mental illness (a disease that makes one very weak and unable to function) and who satisfy all the following criteria, are eligible to participate in the study:

1. Screen positive women with colposcopically suspected high-grade lesions (CIN 2/3) fulfilling the eligibility criteria for ablative treatment. Biopsies will be obtained from the cervical lesion(s) prior to treatment and the results will be reviewed post-treatment.

2. Women with histopathologically confirmed CIN 2/3 fulfilling the eligibility criteria for ablative treatment.

3. Women provide informed consent voluntarily

1. Age < 25 years or > 59 years

2. Pregancy test positive

3. Debilitating physical or mental illness

4. Cervical cancer screen test negative

5. Histology is normal or shows low-grade lesions (CIN 1)

6. Declines to give consent

1. Pain control with lignocaine 

2. Cure rate at 12 months 

3. Residual/persistent disease at 12 months 

9.0 DESIGN OF THE TRIAL

If controlled