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Enrolling by invitationNCT07059819Updated Sep 2, 2026

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

An interventional study of Local hyperthermia device in Cervical Intraepithelial Neoplasia (CIN) and Human Papillovirus, sponsored by First Hospital of China Medical University. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Cervical Intraepithelial Neoplasia (CIN)
  • Human Papillovirus
03

In context

Uterine Cervical Dysplasia

409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.

This study's planned enrollment of 400 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.

Browse Uterine Cervical Dysplasia studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV for persistent at least 3 months; Cervical CIN or no cytological changes; signed

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Local Hyperthermia

    Device: Local hyperthermia device

  • Placebo comparator
    Placebo

    Device: Local hyperthermia device

Interventions

  • DeviceLocal hyperthermia device

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

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What researchers measure

Primary outcomes

  1. Clearance of high-risk HPV

    Detection of HPV genotype by PCR (21 subtypes)

    Time frame: 3 and 6 months after treatment

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07059819
Lead sponsor
First Hospital of China Medical University
Responsible party
Gao Xinghua (Professor, First Hospital of China Medical University) — Principal investigator
First posted
Jul 11, 2025
Start date
Nov 2, 2024
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Sep 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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