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
- KCT0003382
- Lead Sponsor
- ALPINION MEDICAL SYSTEMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 29
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 MR or US imaging
5. If myoma size is more than 3cm and less than 12cm
6. Unless 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
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. MRI taboo (including closure phobia)
8. MRI contrast agents taboo
9. If the number or volume of uterine myomas can not be measured by MRI
10. If the glomerular filtration rate (GFR) is less than 30 ml / min
11. When communication is difficult
12. Can not lie down comfortably
13. Patients who have participated in other clinical trials within the past month
14. Hypervascular myoma
15. 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