Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Local hyperthermia device.
- Who it may be relevant to
- Registry conditions: Cervical Intraepithelial Neoplasia (CIN), Human Papillovirus. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias 3 Months After Treatment: a Multicenter, Single-blind, Randomized Controlled Trial
Overview
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
- Device Local hyperthermia device
Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.
Primary outcome measures
- Clearance of high-risk HPV [Time frame: 3 and 6 months after treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07059819 · HH20241031