Cervical Intraepithelial Neoplasia (CIN)NCT07059819
Local Hyperthermia for the Treatment of Cervical Persistent High-risk Infection
A study testing Local hyperthermia device in people with Cervical Intraepithelial Neoplasia (CIN) and Human Papillovirus, run by First Hospital of China Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia (CIN), Human Papillovirus
- What is being tested?
- Local hyperthermia device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias 3 Months After Treatment: a Multicenter, Single-blind, Randomized Controlled Trial
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.
- Being tested
- Local hyperthermia device
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local hyperthermia deviceDevice
Local hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18.
| Study group | Role | What they receive |
|---|---|---|
| Local Hyperthermia | Experimental | Not described Receives: Device: Local hyperthermia device |
| Placebo | Placebo comparator | Not described Receives: Device: Local hyperthermia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of high-risk HPV
Detection of HPV genotype by PCR (21 subtypes)
Measured: 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start2 Nov 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia (CIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinghua, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059819
- Sponsor's protocol ID
- HH20241031
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias 3 Months After Treatment: a Multicenter, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07059819
- Acronym / sponsor ID
- HH20241031
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Hyperthermia | Experimental | Device: Local hyperthermia device |
| Placebo | Placebo comparator | Device: Local hyperthermia device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local hyperthermia deviceLocal hyperthermia at 44℃ for 30 mins on cervical region, at days of 1,2,3 and 17, 18. | Device | Local Hyperthermia, Placebo |
Primary outcome
Clearance of high-risk HPV
Time frame: 3 and 6 months after treatment
Detection of HPV genotype by PCR (21 subtypes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local hyperthermia device in people with Cervical Intraepithelial Neoplasia (CIN) and Human Papillovirus, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of high-risk HPV (time frame: 3 and 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.