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ENROLLING BY INVITATION
NCT07059819
NA

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

Sponsor: First Hospital of China Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-11-02

Completion Date

2026-10-01

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DEVICE

Local hyperthermia device

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

Locations (1)

the First Hospital of China Medical University

Shenyang, Liaoning, China