Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection

Launched by FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY · Jul 1, 2025

Keywords

ClinConnect Summary

This study is testing whether a local heating treatment (local hyperthermia) can help clear high-risk HPV infections and early cervical cell changes (called CIN) in adult women. Participants are randomly assigned to receive the active heating treatment or a sham device that looks the same but does not heat. The main goal is to see if the heating helps remove high-risk HPV from the cervix at 3 and 6 months after treatment, with HPV checked by a lab test that looks for 21 HPV subtypes.

Who can join: women aged 18–65 who are otherwise in good gynecologic health, have had persistent high-risk HPV for at least 3 months, and have either a cervical biopsy showing CIN or no cytology changes. They must sign informed consent and agree to follow-up visits. Exclusions include pregnancy, recent gynecologic treatment, other serious gynecologic infections or illnesses, or inability to complete follow-up. The treatment involves placing a device on the cervix to heat it to about 44°C for 30 minutes on days 1–3 and again on days 17–18 after enrollment. The study is being conducted (at least in part) at the First Hospital of China Medical University in Shenyang, China, and uses a double-blind-like design so participants, doctors, and those evaluating results don’t know which group a person is in. Results are not yet available; enrollment is about 400 people, and the study is expected to finish around October 2026.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV for persistent at least 3 months; Cervical biopsy CIN or no cytological changes; signed informed consent
• Exclusion Criteria:
• • Pregnant woman; local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses; no guarantee of timely treatment and follow-up.