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Cervical Thermal Ablation to Treat Persistent HPV Infection

NCT07376031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2026-02-06

No results posted yet for this study

Summary

Thermal ablation of women ≥40 years of age with persistent Human papillomavirus (HPV) infection. A pilot and intervention study.

Cervical heat treatment is a relatively new form of treatment19 where a smaller, defined area of the cervix is destroyed by insertion of a heated probe. Cervical heat treatment is already used in specialist medical practice for patients with erythroplakia, contact bleeding, chronic cervicitis and discharged. In a collaboration between Region Zealand and the Capital Region of Denmark, 120 women are randomized to receive thermal ablation for HPV infections without severe disease with a matched control group of 120 women who do not receive ablation. All women are monitored through repeated cervical cytology re-tests at defined follow-up (FU) times. The study cohort consist of 1) sample on enrollment date, 2) 3 months FU sample, 3) 6 months FU sample, 4) 12 months FU sample. All samples are collected in SurePath liquid-based cytology medium and HPV tested using the BD Onclarity HPV test (BD Integrated Diagnostic systems, Sparks, MD)20-22 supplemented by a full genotyping analysis (Seegene, Seoul, Korea)21,23. Methylation status is examined using the QiaSure FAM19A4/miRNA 122-4 methylation test (Qiagen, Hilden, Germany).

This project element aims to determine whether thermal ablation impact viral clearance compared to the control group, and whether DNA methylation status is significant amongst women who are persistently HPV positive before and after thermal ablation.

Conditions

  • Cervical Cancer Screening
  • HPV
  • Thermal Ablation

Interventions

PROCEDURE

Treatment

Thermal ablation was performed using the WISAP Probe 6004/6005/6002 at 65 degrees Celsius for 2 minutes, and at 100 degrees Celsius for 40 seconds as defined in Danish guidelines. In the absence of visible lesions, the entire transformation zone was treated. For transformation zones extending into the endocervical canal (type 3), treatment was applied to the visible ectocervix, recognizing the technical limitations of thermal ablation for endocervical disease. Ablation treatment was administered as two consecutive treatments 2-3 days apart at the gynecologist´s discretion.

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Jesper Bonde, PhD · AHH-Hvidovre Hospital

  • Charlotte Floridon, MD · Gynecological Clinic, Holbæk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT07376031 on ClinicalTrials.gov