KCT0003500已完成未知
A prospective, single-center, single-group, Investigator initiated clinical trial to evaluate the safety and efficacy of 'ALPIUS' (US-guided HIFU System, ultrasound-guided high-intensity focused ultrasound)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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