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Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

NCT05211271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-10-02

No results posted yet for this study

Summary

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

Conditions

  • Cervical Neoplasia

Interventions

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.

Sponsors & Collaborators

  • Kamenge University Hospital, Burundi University, Burundi

    collaborator UNKNOWN

  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Sylvestre Bazikamwe, MD · Kamenge University Hospital, Burundi University, Bujumbura, Burundi

  • Catherine Sauvaget, MD, PhD · International Agency for Research on Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Burundi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211271 on ClinicalTrials.gov