Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

International Agency for Research on Cancer

Status: Completed

Conditions: Cervical Neoplasia

Treatments: Device: Treatment of cervical neoplasia by thermal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05211271

FM/CE/05/08/2018

Details and patient eligibility

About

Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Full description

The study population consisted of women with an abnormal VIA test or an abnormal colposcopy examination. A total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. They were followed-up at 6 weeks for any complication and re-assessed by VIA and colposcopy at 12 months for any persistent or recurrent lesion and for any adverse event.

Enrollment: 86 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women residing in Burundi and referred to the tertiary hospital after a positive VIA test

Exclusion criteria

• Lesion occupying the 4 quadrants of the cervix
• Not visible squamous columnar junction (not Type 1 TZ)
• Vaginal or endocervical lesion
• Lesion subjective of cervical cancer

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Intervention Arm

Experimental group

Description:

Treatment of cervical neoplasia by thermal ablation

Treatment:

Device: Treatment of cervical neoplasia by thermal ablation