Cervical Thermal Ablation to Treat Persistent HPV Infection

NCT07376031 | Completed

• 2 other identifiers: SJ:845A2971
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• HPV test result after 3 and 10 months

  HPV test of women after intervention or no treatment at 3 and 10 months after inclusion

  up to 10 months follow-up post intervention

Study Arms (2)

No treatment

NO INTERVENTION

Women eligible not receiving thermal ablation

intervention

ACTIVE COMPARATOR

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.

Procedure: Treatment

Interventions

Treatment PROCEDURE

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.

intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with histologically confirmed ≥CIN2
• biopsies lacking transformation zone tissue

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Dept. Pathology, AHH-Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Jesper Bonde, PhD

  AHH-Hvidovre Hospital

  STUDY CHAIR

• Charlotte Floridon, MD

  Gynecological Clinic, Holbæk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)