Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

Inclusion Criteria:

• Women with symptomatic and medically untreatable uterine fibroids who score at least 40 points on the Symptom Severity Score (SSS) of the Uterine Fibroid Symptom andQuality of Life Questionnaire (UFS- QoL )

• Safe access for the MRgFUS possible (anatomical position of the fibroids): Pelvicmagnetic resonance imaging to document the number, location and size of fibroids andto exclude malignancy and other pelvic pathologies; necessary to determine whetherMRgFUS can be performed technically (presence of a stable ultrasound window andexclusion of scars in the access path)

• ≤ 5 fibroids requiring treatment

• Fibroids with a diameter ≤ 10 cm

• Total myoma volume ≤ 400 ml

• Patient is suitable for treatment with MRgFUS-TUF as well as for myomectomy

• Desire for least invasive treatment

• Indication for hysteroscopy and fractionated abrasion depending on the bleedingpattern and endometrial thickness and structure have been critically tested inadvance.

• inconspicuous cytological smear of the cervix uteri not older than 12 months

• No previous uterine surgery / intervention

• Female patients aged> 18 years. Patients of reproductive age must adhere toappropriate contraception until 6 months after the procedure. (Methods ofcontraception that meet the criteria of highly effective contraception in the senseof the Note for guidance on non- clinical safety studies for the conduct of humanclinical trials for meet pharmaceuticals [CPMP / ICH / 286/95 mod ]). Patients ofchildbearing potential must have a negative pregnancy test within 7 days prior toenrollment.

• Karnofsky index ≥ 70

• Given medical operability

• Written consent of the patient

Exclusion Criteria:

• Pretreatment with ulipristal acetate ( Esmya ) ≤ 2 months

• Suspected Malignancy (absolute)

• Pregnancy (absolute)

• acute inflammatory process (absolute)

• Uterus myomatosis with more than 5 fibroids (relative, case-by-case decision)

• Uterine fibroids with a diameter over 10 cm (absolute)

• insufficient sound window can be reached for treatment (eg intestinal overlays,large scars in the acoustic window, very dorsal position of the fibroid)

• subserous stalked fibroids

• Inaccessible location of fibroids

• Scarring in the treatment area

• Recurring abortions

• general contraindications to MR contrast agents

• MRI contraindications

• Presence of pacemaker or metal implants

• Karnofsky Index <70

• Severe hepatic dysfunction (Aspartat-Aminotransferase (AST) / TransaminasenAlanin-Amino-transferase (ALT)> 3.5x ULN (upper limit of normal), AlkalischePhosphatase (AP)> 6xULN)

• Active CHD (congenital heart disease), (symptoms present), cardiomyopathy or heartfailure in NYHA (New York Heart Association) and EF (ejection fraction) stage III-IV <45%

• Serious internistic side-diseases or an acute infection

• Chronic inflammatory bowel disease

• Pregnancy or lactation

• Participation in another interventional study