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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07059819

Enrollment

400

Registered

2025-07-11

Start date

2024-11-02

Completion date

2026-10-01

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia (CIN), Human Papillovirus

Brief 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.

Interventions

DEVICELocal hyperthermia device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clearance of high-risk HPV	3 and 6 months after treatment	Detection of HPV genotype by PCR (21 subtypes)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026