NCT07059819

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

Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias 3 Months After Treatment: a Multicenter, Single-blind, Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required. Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilized in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with HR-HPV in cervical area. So the purpose of the study is to evaluate the effective of local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months. Appropriate control arms were designed for different conditions.

Conditions

• Cervical Intraepithelial Neoplasia (CIN)
• Human Papillovirus

Interventions

Type	Name	Description
DEVICE	Local hyperthermia device	Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.

Timeline

• Start date: 2024-11-02
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-07-11
• Last updated: 2025-08-13

Locations

1 site across 1 country: China