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Stiffness check could boost fibroid treatment success

NCT ID NCT04345003

Knowledge-focused Sponsor: University Hospital, Bordeaux 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether measuring the stiffness of uterine fibroids can help predict how well they respond to a non-invasive treatment called MR-HIFU. Forty women with symptomatic fibroids were enrolled. The goal was to improve patient selection so that only those likely to benefit receive the treatment.

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

40 people

The number who actually took part.

Started

Jun 2020

Finished

Aug 2023

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 years and older

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: * Woman * Aged more than 18 years * Not postmenopausal * Having one or two symptomatic fibroid with size \< 15cm. * Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI * Normal cervicovaginal smear performed within 2 years prior to inclusion * Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI * SSS score on UFS-Qol ≥ 10 * Signed informed consent prior to any study related procedure * With a medical insurance Exclusion Criteria: * Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..). * Presence or suspicious of pelvic malignant tumor * Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl) * Pregnant or lactating woman * Small submucous myoma accessible for hysteroscopic treatment. * Active pelvic infection * Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.

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Conditions

The condition(s) this trial relates to.

leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

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

Uterine fibroid

Contacts and locations

Locations

  • CHU Bordeaux

    Bordeaux, France

More trials for these conditions

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