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Sound waves vs. watchful waiting: can HIFU clear cervical lesions faster?

NCT ID NCT07461064

Disease control Sponsor: Queen Mary Hospital, Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a non-invasive ultrasound treatment (HIFU) to standard observation for low-grade cervical lesions (LSIL/CIN1) in 180 pre-menopausal women. Most of these lesions go away on their own, but the trial aims to see if HIFU can speed up clearance of the lesion and the HPV virus. Participants are randomly assigned to receive HIFU or no treatment, and are followed for 12 months with cervical smears and HPV tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pre-menopausal women aged 18 years old or above. 2. Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1. Exclusion Criteria: 1. Women who are pregnant or breast feeding at the time of planned HIFU treatment. 2. Women without HR-HPV, or previously treated for CIN or cervical cancer. 3. Women not able to attend follow up. 4. Women with evidence of acute genital tract infection. 5. Women with significant autoimmune diseases, immunodeficiency diseases, severe cardiac, hepatic, renal, and coagulation dysfunctions. 6. Women not able to give consent. Participants be considered withdrawn from study or excluded from analysis 1. Formally recruited into the study but withdraw from the study after randomization. 2. Do not attend both follow-up appointments.

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical squamous intraepithelial neoplasia human papilloma virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical intraepithelial neoplasia grade I HPV disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.