Clinical trial · Interventional
Cervical Thermal Ablation to Treat Persistent HPV Infection
Effect of Thermal Ablation on Persistent HPV Infection in Danish Women ≥40 Years of Age; a Randomized Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening | — | UNRESOLVED | — |
| HPV | — | UNRESOLVED | — |
| Thermal Ablation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No treatment
- description
- Women eligible not receiving thermal ablation
- type
- ACTIVE_COMPARATOR
- label
- intervention
- description
- 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.
- interventionNames
- Procedure: Treatment
Primary outcomes (1)
- measure
- HPV test result after 3 and 10 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Women, age ≥40 years; * persistent high-risk human papillomavirus (HR-HPV) infection for ≥12 months * colposcopy referral according to national screening guidelines; * normal, ASC-US, or LSIL cytology; * no histologically verified ≥CIN2; and no prior cervical treatment. Exclusion Criteria: * Women with histologically confirmed ≥CIN2 * biopsies lacking transformation zone tissue
References
Publications (0)
Data not yet available