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Evaluation of suitable criteria for the therapy of uterine fibroids by MR-guided high-intensity focused ultrasound (MR-HIFU)

Evaluation of suitable criteria for the therapy of uterine fibroids by MR-guided high-intensity focused ultrasound (MR-HIFU) - HIFU-Myom

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013526
Enrollment
75
Registered
2018-05-25
Start date
2018-06-06
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D25.0 D25.1

Interventions

Group 1: The patient is evaluated interdisciplinarily by the treating gynecologist with the request for treatment of a complaint-causing finding (uterine fibroma) and is called for an indication for r

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age of at least 18 years. 2. Current creatinine 3. Indication for local ablative therapy by means of HIFU 4. Accessibility of the fibroid / fibroids with HIFU 5. Funaki Type I-II 6. Signed declaration of consent with compliance incl. Follow-up treatment with compliance including follow-up treatment 7. Size of fibroid <12 cm 8. Exclusion of a leiomyosarcoma 9. Signed declaration of consent

Exclusion criteria

Exclusion criteria: 1. Taking Ulipristalacetat (Esmya) over the past 6 months 2. General MRI contraindications (pacemakers, metal parts) 3. contrast agent allergy 4. Significantly reduced general condition 5. Massive obesity (BMI> 40) 6. Patients with mental / psychiatric disorders 7. pregnancy 8. intrauterine Device 9. Funaki Type III-IV 10. Pedunculated serous fibroid 11. Detection of a Leiomyosarcoma

Design outcomes

Primary

MeasureTime frame
Achievement of the final follow-up (12 months) or performing any additional myoma therapy (e.g., myomactomy, hysterectomy, or Radiofrequency Ablation (RFA))

Countries

Germany

Contacts

Public ContactChristel Besseler

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

christel.besseler@med.uni-muenchen.de(089) 4400-44462

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026