Safety & Efficacy of Non-Invasive Procedures Using Ultrasound-Guided HIFU 'Sonotrip V20' in Symptomatic Uterine Fibroids

Inclusion Criteria:

1. adult women 19 years of age or older
2. with symptomatic uterine fibroids\* (e.g., heavy periods, dysmenorrhea, abnormal bleeding, pressure symptoms including pelvic pain, and urinary and bowel dysfunction)12

   \*Symptomatic fibroids: a Symptom Severity Score (SSS) score of 41 or higher on the UFS-QOL questionnaire for fibroid symptoms.
3. premenopausal (FSH\<40 mIU/ml)
4. For women of childbearing potential, agree to use at least one clinically adequate method of contraception\* for the duration of the study.

   \* Clinically adequate contraception is defined as "\[intrauterine device (e.g., Loop, Mirena), chemical barrier method (spermicide), or subdermal implant (e.g., Implanon)\] + physical barrier method (male or female)", tubal surgery, or laparoscopic contraception (a type of tubal ligation).
5. have been diagnosed with fibroids by imaging studies.
6. have four or fewer fibroids to be treated
7. the size of the fibroids to be treated is 12 cm or less with no necrotic or calcified areas13
8. have voluntarily decided to participate in this study and have given written consent to the informed consent form and the study protocol
9. willing to comply with the protocol

Exclusion Criteria:

1. suspected intrauterine malignancy on contrast MR scan (however, if endometrial biopsy confirms that the lesion is not malignant, the patient may be eligible to participate in the study)14, 15, 16
2. the lesion to be treated is adenomyosis or highly perfused fibroid\*17

   \*highly perfused fibroid is defined as having an image intensity equal to or greater than the myometrium on T2-weighted images.
3. Planning to become pregnant in the future, or currently pregnant (women of childbearing potential who are β-hCG positive are not eligible to participate in the study).
4. Have a contraindication to MRI examination (e.g., claustrophobia) or a history of hypersensitivity to gadolinium-based contrast agents (MR contrast agents) or ultrasound contrast agents However, if any of the above can be controlled with medication, patients may be eligible to participate in the study.
5. currently being treated with or having been treated with gonadotropin-releasing hormone agonists (GnRHa) (however, if 12 weeks have elapsed since the end of GnRHa treatment, patients may participate in the study)
6. the fibroids to be treated are not measurable on MRI
7. the location of the fibroids to be treated falls into type 7 and/or type 8 according to the following classification