Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Cervical Neoplasia Clinical Trial

Official title:

Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211271
• Other study ID #: FM/CE/05/08/2018
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2022
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Neoplasia
• Neoplasms

Intervention

Device:
• Treatment of cervical neoplasia by thermal ablation
Women screened for cervical cancer by visual inspection with diluted acetic acid (VIA) presenting lesions eligible for ablative treatment were treated by thermal ablation. The treatment consisted in applying the probe on the lesion for 45 seconds at 100 degrees Celsius, with one to up to five applications depending on the lesion size. Following treatment, women were inquired about the pain level during the procedure, their satisfaction level of the procedure and whether they would recommend this treatment to their relatives. Women had a follow-up visit at 6 weeks to assess any complication of the procedure. Women were rescreened at 12 months, to evaluate the cure rate and any long-term adverse events.

Locations

Country	Name	City	State
Burundi	Kamenge University Hospital	Bujumbura

Sponsors (2)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Kamenge University Hospital, Burundi University, Burundi

Country where clinical trial is conducted

Burundi, 

References & Publications (1)

Sauvaget C, Bazikamwe S, Lucas E, Ndayikengurukiye A, Harerimana S, Barango P. Evaluation of effectiveness, acceptability and safety of thermal ablation in the treatment of cervical neoplasia in Burundi. Int J Cancer. 2022 Oct 1;151(7):1120-1126. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate based on VIA and colposcopy assessment	Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment.	1 year
Primary	Acceptability of thermal ablation	Measured by existence of minor/moderate adverse events during the follow-up.	6 weeks
Primary	Acceptability of thermal ablation	Measured by the satisfaction level using a nine-level Likert scale (from 1. Very unsatisfied to 9. very satisfied).	At day 1
Primary	Safety of thermal ablation	Measured by existence of severe adverse events during the follow-up period.	1 year