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

Not Applicable

Recruiting

• Conditions: D25.0; D25.1; Submucous leiomyoma of uterus; Intramural leiomyoma of uterus

• Registration Number: DRKS00013526
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 75

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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