None listed
Conditions
Interventions
Medical Device : - On the scheduled treatment day, analgesics will be administered to the subject.
- HIFU treatment will be performed using the investigational medical device in accordance with the pr
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female subjects aged 19 years or older. 2. Subjects diagnosed with uterine fibroids accompanied by symptoms (e.g., menorrhagia, dysmenorrhea, abnormal uterine bleeding, pelvic pain including pressure symptoms, urinary or bowel dysfunction). Symptomatic uterine fibroids are defined as those with a Symptom Severity Score (SSS) of =41 on the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire. 3. Premenopausal status (FSH < 40 mIU/mL). 4. For women of childbearing potential, willingness to use at least one clinically acceptable method of contraception during the study period. Clinically acceptable methods of contraception are defined as “[intrauterine devices (e.g., copper IUD, Mirena), chemical barrier methods (e.g., spermicides), or subdermal implants (e.g., Implanon)] + physical barrier methods (male or female condoms)”, or surgical sterilization (e.g., tubal ligation or laparoscopic sterilization). 5. Diagnosis of uterine fibroids confirmed by imaging studies. 6. Having four or fewer fibroids requiring treatment. 7. The size of each fibroid requiring treatment must be =12 cm in diameter, with no evidence of necrosis or calcification. 8. Willing and able to voluntarily participate in this clinical trial and provide written informed consent after being fully informed. 9. Willing and able to comply with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. In case of suspecting a malignant tumor in the uterine on the MR images. (However, if it is turned out benign tumor by endometrial tissue test, the patient can use this product) 2. In case of adenomyosis or type of the highly perfused to be treated lesion. 3. The women who wish to have pregnant in the future or have being pregnant currently. (The women of childbearing age can participate in invetigation if they get a negative result through the ß-hcG) 4. Patients have a contraindication to MR examination (e.g. Claustrophobia) and have a history of hypersensitive to contrast agents (Gadolinium MR contrast agent) or Ultrasound contrast agent. However, patients can participate in clinical trials, if they can be controlled by medication about the above issues. 5.Patients have a history of hypersensitivity to or contraindication to one or more of the following medications ? lidocaine ? opioid ? non-steroidal anti-inflammatory drugs, NSAIDs 6. Patients currently receiving or who have previously received GnRHa treatment. (However, if 12 weeks have passed since the end of GnRH treatment, treatment may be performed at the discretion of the attending physician.) 7. Patients with uterine myoma/fibroids that require treatment cannot be accurately measured on MRI. 8 Patients whose uterine myoma/fibroids are located in categories 7 and/or 8 in the classification below will be treated. Classification according to the position of the myoma 9. Patients with scars covering more than 50% of the treatment application area. (At the discretion of the physician, can be treated using the scar patch.) 10. Patients who cannot be lying with supine. 11. Patients who cannot simply communicate with a doctor 12. Patients in whom the previous high-intensity focused ultrasound(HIFU) treatment did not have a sufficient therapeutic effect. 13. Patients with an intrauterine device(IUD). However, if the patient agrees to remove the device before the HIFU treatment, the patient can be taken the HIFU treatment after the device has been removed. 14. Patients who have prosthetic implants, such as surgical clips, may experience burns in the area where ultrasound is applied. 15. When it is unavailable to apply a HIFU device for clinical trials because the lesion cannot be diagnosed with ultrasound images. 16. Patients who had taken a treatment for the abdominal liposuction before. 17. In case of having pelvic inflammatory disease 18. If the laboratory test results meet one or more of the below following: A ? Hct(Hematocrit): < 25% B ? GFR(Glomerular filtration): = 30ml/min 19. Patients, whose abdominal wall thickness is 5cm or more from the pathway HIFU treatment on the MR imaging. 20. The patients have a serious systemic disease (e.g. uncontrollable high blood pressure, uncontrollable diabetes, uncontrollable heart disease, cancer under treatment, etc.) 21. Patients who are being in another clinical trial or who had taken in another clinical trial within 30 days from the day screening. 22. In other cases, if the investigator determines that participation in the clinical trial is inappropriate because it may affect the results of the clinical trial or ethically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in uterine fibroid volume | — |
Secondary
| Measure | Time frame |
|---|---|
| NPVR(Non-Perfused Volume Ratio, %);Quality of life assessments (SF-36v2 and UFS-QOL questionnaires);Changes in hemoglobin (Hb) and hematocrit (Hct) levels (%) after treatment;Change in pain intensity (Numerical Rating Scale, NRS score) | — |
Countries
Korea, Republic of
Contacts
Public ContactKidong Kim
Seoul National University Bundang Hospital
Outcome results
None listed