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Sound waves vs. scalpel: new trial tests ultrasound as fibroid fix

NCT ID NCT06692335

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 High-Intensity Focused Ultrasound (HIFU), a non-invasive procedure using sound waves to destroy fibroids, to myomectomy, a surgical removal. About 112 women aged 18-50 with symptomatic fibroids will be randomly assigned to one treatment. Researchers will track quality of life, recovery, and complications over 6 months to see if HIFU is a good alternative to surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-Intensity Focused Ultrasound (HIFU)
What this could lead to
If HIFU works as well as surgery, it could offer a non-invasive option for women with uterine fibroids, reducing recovery time and avoiding surgical risks.
What could go wrong
This is a relatively small trial (112 participants) comparing a newer procedure to standard surgery. HIFU may not be as effective for all fibroid types, and long-term outcomes are not yet known.

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 112 people

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

Started

Feb 2025

Expected to finish

Dec 2027

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 50 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: * Age 18 - 50 years-old * Pre or peri menopausal with FSH less than 25 mIU/ml * BMI \< 33 kg/m2 or abdominal wall thickness \< 5 cm * Uterine size ≤18 weeks based on physical exam assessment * Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging * Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain * Willing and able to give informed consent Exclusion Criteria: * Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease * Morbid obesity * Inability to lie in a prone position for more than 2 hours * Extensive abdominal scar on the acoustic channel * Women with pregnancy, lactation or menopause * Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI * Rapid growth of fibroids, defined as a doubling in size in 6 months * History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke) * Coagulation problem or using medication which affect clotting function * History of pelvic irradiation * Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter * Cervical/ broad ligament fibroid * Contraindication to MRI due to severe claustrophobia or implanted metallic device. * Co-existing adenomyosis

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Conditions

The condition(s) this trial relates to.

Dysmenorrhea leiomyoma Menorrhagia uterine corpus leiomyoma

As listed by the trial registrant

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

Uterine fibroids (UF)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • The Chinese University of Hong Kong

    RECRUITING

    Hong Kong, Hong Kong

More trials for these conditions

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