A prospective study to evaluate the safety and efficacy of 'ALPIUS'(high intensity focused ultrasound) in patients with uterine leiomyoma
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003500
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 22
1. Adult women over 20 years old
2. Premenopausal or postmenopausal (FSH <40mIU / ml)
3. In case the clinician determines that the uterus size is less than 24 weeks of single pregnancy
4. If myoma is diagnosed by (Magnetic Resonance Imaging)MRI or US(Ultrasound) imaging
5. If myoma size is more than 3cm and less than 12cm
6. Unless (High Intensity Focused Ultrasound)HIFU has received other treatment for uterine fibroids
7. Treatment If the guidelines for selection of uterine myoma are met
8. Willing to voluntarily agree to the clinical trial and willing to follow the protocol
9. Those who agree to use medically acceptable contraception during the trial if there is a possibility of pregnancy. * Medically acceptable contraceptive methods: Condoms, oral contraception for at least 3 months,Injectable contraceptive or implantation contraceptives, intrauterine contraceptive device installed
1. Other pelvic disorders such as other tumors, endometriosis, ovarian tumors, acute pelvic disease
2. If you are pregnant or you are pregnant
3. Severe systemic disease
4. Less than 25% hematocrit
5. If the extensive scarring along the anterior abdominal wall exceeds 50% of the area
6. High intensity focused ultrasound passes through scar, surgical clip
7. Magnetic Resonance Imaging(MRI) taboo (including closure phobia)
8. Megnetic Resonance Imaging(MRI) contrast agents taboo
9. Ultrasound contrast agents taboo
10. If the number or volume of uterine myomas can not be measured by MRI
11. If the glomerular filtration rate (GFR) is less than 30 ml / min
12. When communication is difficult
13. Can not lie down comfortably
14. Patients who have participated in other clinical trials within the past month
15. Hypervascular myoma
16. In addition, if it is judged by the researcher that participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful ablation rate of uterine myoma
- Secondary Outcome Measures
Name Time Method Quality of life;Re-intervention rate;ablated volume shrinkage rate;safety