Evidence map›Paper›PMID 40063166›Full record

Observational studyLa Radiologia medica2025

Ablation of symptomatic uterine fibroids with the Mirabilis system for rapid noninvasive ultrasound-guided high-intensity focused ultrasound (HIFU): a prospective observational clinical study.

Tolga Tonguc, Oleksandr Savchenko, Olga Ramig, Judith M Stader, Franziska Kießling, Jim Küppers, Eva K Egger, Marcus Thudium, Patrick Martin, Wayne Poll and 6 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in La Radiologia medica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Tolga TongucDepartment of Radiology/Neuroradiology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Oleksandr SavchenkoDepartment of Radiology/Neuroradiology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Olga RamigDepartment of Radiology/Neuroradiology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Judith M StaderDepartment of Nuclear Medicine, University Hospital Bonn, University of Bonn, NRW, Venusberg-Campus 1, 53127, Bonn, Germany.
Franziska KießlingDepartment of Nuclear Medicine, University Hospital Bonn, University of Bonn, NRW, Venusberg-Campus 1, 53127, Bonn, Germany.
Jim KüppersDepartment of Nuclear Medicine, University Hospital Bonn, University of Bonn, NRW, Venusberg-Campus 1, 53127, Bonn, Germany.
Eva K EggerDepartment of Gynaecology and Gynaecological Oncology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Marcus ThudiumDepartment of Anaesthesiology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Patrick MartinNalu Medical, Inc, Carlsbad, CA, USA.
Wayne PollApplied Science Management, LLC, Pismo Beach, CA, USA.
Hans H SchildDepartment of Radiology/Neuroradiology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Rupert ConradDepartment of Psychosomatic Medicine, University Hospital Muenster, University of Muenster, Muenster, NRW, Germany.
Markus EsslerDepartment of Nuclear Medicine, University Hospital Bonn, University of Bonn, NRW, Venusberg-Campus 1, 53127, Bonn, Germany.
Alexander MusteaDepartment of Gynaecology and Gynaecological Oncology, University Hospital Bonn, University of Bonn, Bonn, NRW, Germany.
Holger M StrunkUniversity of Bonn, Bonn, NRW, Germany.
Milka MarinovaDepartment of Nuclear Medicine, University Hospital Bonn, University of Bonn, NRW, Venusberg-Campus 1, 53127, Bonn, Germany. milka.marinova@ukbonn.de.ORCID http://orcid.org/0000-0002-1856-5005

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesUterine fibroids often lead to symptoms that negatively impact health-related quality of life (HRQOL). High-intensity focused ultrasound (HIFU) has emerged as a promising noninvasive treatment for reducing fibroid size and symptoms. The Mirabilis system for ultrasound (US)-guided HIFU introduces a novel technique known as 'shell ablation'. This study evaluates the feasibility and efficacy of Mirabilis in a clinical setting, focusing on clinical outcomes. MATERIALS AND

methodsSixteen patients with 23 uterine fibroids were treated with the Mirabilis system. Follow-up assessments included US and MRI at baseline, 6 weeks, 3, 6 and 9 months, and 1 year after HIFU. Changes in symptoms and QOL were evaluated using the Uterine Fibroid Symptom and HRQOL Questionnaire.

resultsA significant reduction in fibroid volume was observed after HIFU (baseline 182.1 ± 49.3 ml; 1 year: 76.0 ± 37.9 ml, p < 0.001). The symptom severity score significantly declined (baseline 57.2 ± 3.8; 1 year: 30.2 ± 4.9, p < 0.001), correlating with a significant improvement in HRQOL (baseline 47.0 ± 3.9, 1 year: 71.8 ± 5.3, p < 0.001).

conclusionHIFU with the portable Mirabilis system is a feasible and safe noninvasive treatment for symptomatic uterine fibroids in an outpatient setting. This approach allows efficient and rapid ablation even for large fibroids, significantly reducing fibroid volume and symptoms.

Indexed as

High-Intensity Focused Ultrasound AblationLeiomyomaUltrasonography, InterventionalUterine NeoplasmsAdultFeasibility StudiesFemaleHumansMagnetic Resonance ImagingMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeFibroid-associated symptomsHigh-intensity focused ultrasoundMirabilis systemMobile deviceShell ablation

Identifiers

PMID40063166
PMCPMC12106475

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.