Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

September 28, 2023 updated by: International Agency for Research on Cancer
Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burundi
      • Bujumbura, Burundi, 2210
        • Kamenge University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Treatment of cervical neoplasia by thermal ablation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Acceptability of thermal ablation
Time Frame: 6 weeks
Measured by existence of minor/moderate adverse events during the follow-up.
6 weeks
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).
At day 1
Safety of thermal ablation
Time Frame: 1 year
Measured by existence of severe adverse events during the follow-up period.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Collaborators

Kamenge University Hospital, Burundi University, Burundi

Investigators

  • Principal Investigator: Sylvestre Bazikamwe, MD, Kamenge University Hospital, Burundi University, Bujumbura, Burundi
  • Principal Investigator: Catherine SAUVAGET, MD, PhD, International Agency for Research on Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FM/CE/05/08/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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