Skip to main content
OpenTrials
Completed

NCT Number: NCT05211271

Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Neoplasia

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kamenge University Hospital

Bujumbura, 2210, Burundi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of cervical neoplasia by thermal ablation

Device

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.

Primary outcomes

  1. Cure rate based on VIA and colposcopy assessment

    Time frame: 1 year

    Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment.

  2. Acceptability of thermal ablation

    Time frame: 6 weeks

    Measured by existence of minor/moderate adverse events during the follow-up.

  3. Acceptability of thermal ablation

    Time frame: At day 1

    Measured by the satisfaction level using a nine-level Likert scale (from 1. Very unsatisfied to 9. very satisfied).

  4. Safety of thermal ablation

    Time frame: 1 year

    Measured by existence of severe adverse events during the follow-up period.

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • Kamenge University Hospital, Burundi University, Burundi

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2022
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.