HPV DiseaseHIFU ColpoNCT07461064
HIFU vs Observation for LSIL of Cervix: A Randomized Controlled Trial
A study testing HIFU treatment in people with HPV Disease and Cervical Intraepithelial Neoplasia Grade I, run by Queen Mary Hospital, Hong Kong.
Trial summary
The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- HPV Disease, Cervical Intraepithelial Neoplasia Grade I
- What is being tested?
- HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2028
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal women aged 18 years old or above.
- Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1.
Who cannot join
- Women who are pregnant or breast feeding at the time of planned HIFU treatment.
- Women without HR-HPV, or previously treated for CIN or cervical cancer.
- Women not able to attend follow up.
- Women with evidence of acute genital tract infection.
- Women with significant autoimmune diseases, immunodeficiency diseases, severe cardiac, hepatic, renal, and coagulation dysfunctions.
- Women not able to give consent.
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- Participants be considered withdrawn from study or excluded from analysis
- Formally recruited into the study but withdraw from the study after randomization.
- Do not attend both follow-up appointments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-Intensity Focused Ultrasound (HIFU) Versus Observation for Low-Grade Squamous Intraepithelial Lesions of Cervix: A Randomized Controlled Trial
The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. According to the Hong Kong College of Obstetricians and Gynaecologists (HKCOG), if a low-grade lesion is confirmed by colposcopy and biopsy, the patient can be observed and followed up with HPV testing or co-testing at 12 months, irrespective of age. This randomized controlled study is to determine whether high-intensity focused ultrasound (HIFU) treatment of low-grade pre-invasive lesions of cervix, can cause regression of these lesions in more patients within a specific time when compared to observation as a standard management according to HKCOG Guidelines. All eligible patients will be randomized in a 1:1 ratio into 2 groups: high-intensity focused ultrasound (HIFU) or Observation group. Background information of the patients such as age, parity, body mass index, smoking status and the presence of chronic medical disease will be collected. All patients with cervical HR-HPV status will be tested. Patients randomized into HIFU group will receive HIFU treatment within 2 weeks after randomization. Those randomized into Observation group will have no intervention. All patients will attend follow-up at 6 and 12 months after randomization, during which cervical smear for cytology (with cytopathologists blinded to the treatment group) and HR-HPV testing will be performed. The rate of cytological LSIL regression and HR-HPV clearance rates at 6 and 12 months in both groups will be analyzed. Patients will be referred back to colposcopy clinic for repeat colposcopy if needed according to HKCOG Guidelines. At the 12-month follow-up visit, if referral to repeat colposcopy is not needed, patients will be referred back to their primary care physicians, Department of Health Family Health Service, Family Planning Association or other primary care centres for follow-up cervical smears.
- Being tested
- HIFU treatment
- Keywords
- Cervical HR-HPV-related low-grade squamous intraepithelial lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentDevice
HIFU for the management of cervical HR-HPV-related LSIL
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment group | Active comparator | high-intensity focused ultrasound (HIFU) for the management of cervical HR-HPV-related LSIL Receives: Device: HIFU treatment |
| observation group | No intervention | Observation group as a standard management according to HKCOG Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of HIFU in reducing cervical HR-HPV related LSIL
- To determine the efficacy of HIFU in reducing cervical HR-HPV-related LSIL as evident by the reduction in the number of persistent cervical smear cytological abnormality when compared to observation as a standard management according to HKCOG Guidelines.
Measured: 12 months
Secondary outcomes (4)
efficacy of HIFU in clearing cervical HR-HPV
The efficacy of HIFU in clearing cervical HR-HPV-related HPV will be compared to observation. Both HIFU and Observation group will have HPV testing at 6 and 12 months after recruitment, and the incidence of HR-HPV in both groups will be analyzed.
Measured: 12 months
Efficacy of HIFU in reducing the need for repeat colposcopy
The number of participants that required repeat colposcopy for persistent abnormal cervical smear in HIFU and Observation group will be compared.
Measured: 12 months
Safety and side effects of HIFU in the treatment of cervical LSIL
The treatment time, intraoperative blood loss, intraoperative pain level using visual analog scale (VAS) pain score, and other discomfort are recorded. Patients will be called in 1 week for any postoperative side effects or complications such as discharge, bleeding, pain (including the VAS pain score) or discomfort, for which, additional telephone or clinic follow-up will be arranged if necessary. The visual analog scale pain score will range from a minimum value of 0 to a maximum value of 10, with higher scores mean worse pain level.
Measured: 6 months
Patient satisfaction in using HIFU in the treatment of cervical LSIL
The level of patient satisfaction in using HIFU in the treatment of cervical LSIL level will be evaluated using visual analog scale (VAS) score, immediately after, and 1 month after HIFU treatment. The visual analog scale patient satisfaction score will range from a minimum value of 0 to a maximum value of 5, with higher scores mean higher satisfaction.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV DiseaseStudies 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vincent YT Cheung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461064
- Sponsor's protocol ID
- UW25-292
- Acronym
- HIFU Colpo
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Focused Ultrasound (HIFU) Versus Observation for Low-Grade Squamous Intraepithelial Lesions of Cervix: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07461064
- Acronym / sponsor ID
- HIFU Colpo / UW25-292
- Keywords
- Cervical HR-HPV-related low-grade squamous intraepithelial lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. According to the Hong Kong College of Obstetricians and Gynaecologists (HKCOG), if a low-grade lesion is confirmed by colposcopy and biopsy, the patient can be observed and followed up with HPV testing or co-testing at 12 months, irrespective of age. This randomized controlled study is to determine whether high-intensity focused ultrasound (HIFU) treatment of low-grade pre-invasive lesions of cervix, can cause regression of these lesions in more patients within a specific time when compared to observation as a standard management according to HKCOG Guidelines. All eligible patients will be randomized in a 1:1 ratio into 2 groups: high-intensity focused ultrasound (HIFU) or Observation group. Background information of the patients such as age, parity, body mass index, smoking status and the presence of chronic medical disease will be collected. All patients with cervical HR-HPV status will be tested. Patients randomized into HIFU group will receive HIFU treatment within 2 weeks after randomization. Those randomized into Observation group will have no intervention. All patients will attend follow-up at 6 and 12 months after randomization, during which cervical smear for cytology (with cytopathologists blinded to the treatment group) and HR-HPV testing will be performed. The rate of cytological LSIL regression and HR-HPV clearance rates at 6 and 12 months in both groups will be analyzed. Patients will be referred back to colposcopy clinic for repeat colposcopy if needed according to HKCOG Guidelines. At the 12-month follow-up visit, if referral to repeat colposcopy is not needed, patients will be referred back to their primary care physicians, Department of Health Family Health Service, Family Planning Association or other primary care centres for follow-up cervical smears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment group | Active comparator | Device: HIFU treatmenthigh-intensity focused ultrasound (HIFU) for the management of cervical HR-HPV-related LSIL |
| observation group | No intervention | –Observation group as a standard management according to HKCOG Guidelines |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pre-menopausal women aged 18 years old or above.
- Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1.
Key exclusion criteria (9 listed)
- Women who are pregnant or breast feeding at the time of planned HIFU treatment.
- Women without HR-HPV, or previously treated for CIN or cervical cancer.
- Women not able to attend follow up.
- Women with evidence of acute genital tract infection.
- Women with significant autoimmune diseases, immunodeficiency diseases, severe cardiac, hepatic, renal, and coagulation dysfunctions.
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 |
|---|---|---|
| HIFU treatmentHIFU for the management of cervical HR-HPV-related LSIL | Device | HIFU treatment group |
Primary outcome
Efficacy of HIFU in reducing cervical HR-HPV related LSIL
Time frame: 12 months
- To determine the efficacy of HIFU in reducing cervical HR-HPV-related LSIL as evident by the reduction in the number of persistent cervical smear cytological abnormality when compared to observation as a standard management according to HKCOG Guidelines.
4 secondary outcomes
efficacy of HIFU in clearing cervical HR-HPV
Time frame: 12 months
Efficacy of HIFU in reducing the need for repeat colposcopy
Time frame: 12 months
Safety and side effects of HIFU in the treatment of cervical LSIL
Time frame: 6 months
Patient satisfaction in using HIFU in the treatment of cervical LSIL
Time frame: 1 months
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided. not yet decided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in people with HPV Disease and Cervical Intraepithelial Neoplasia Grade I, run by Queen Mary Hospital, Hong Kong.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Vincent YT Dr. Cheung, MBBS, MRCOG, FHKAM, FRCOG (+85222554265, vytc@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HIFU in reducing cervical HR-HPV related LSIL (time frame: 12 months). 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 10 Mar 2026.