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NCT07059819

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

ENROLLING BY INVITATION NA Last updated 13 August 2025
What this trial tests

NA trial testing Local hyperthermia device in Cervical Intraepithelial Neoplasia (CIN) in 400 participants. Enrolling by invitation.

Timeline
2 November 2024
Primary endpoint
1 October 2026
1 October 2026

Quick facts

Lead sponsorFirst Hospital of China Medical University
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment400
Start date2 November 2024
Primary completion1 October 2026
Estimated completion1 October 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Hospital of China Medical University

Who can join

Adults 18 to 65, female only, with Cervical Intraepithelial Neoplasia (CIN) or Human Papillovirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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