KCT0003586已完成未知
A prospective, single-center, single-group clinical trial to evaluate the safety and efficacy of 'ALPIUS' (US-guided HIFU System, ultrasound-guided high-intensity focused ultrasound) in patients with uterine adenomyosis.
ALPINION MEDICAL SYSTEMS0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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(Follicle stimulating hormone) <40mIU / ml)
- •3) Clinically diagnosed adenomyosis with MR(Magnetic resonance imaging) or US(Ultrasound) imaging
- •4) Clinical findings based on MR or US images suggest that focal adenomyosis is localized in the uterine adenomyoma
- •5) If the pain score on the dysmenorrhea index is 4 points or more
- •1 = Not at all
- •2 = A little bit
- •3 = Somewhat
- •4 = A great deal
- •5 = A very great deal
- •6) If you have not received any other treatment for adenomyosis within 3 months before the HIFU(High Intensity Focused Ultrasound) procedure
- •7) If you voluntarily agree to the clinical trial and you are willing to follow the test plan
- •8) Those who agree to use medically accepted contraception during the trial if there is a possibility of pregnancy.
- •*Medically acceptable contraceptive methods: condoms, oral contraception for at least 3 months, use of contraceptives for injection or use, placement of intrauterine contraceptive devices, etc.
排除标准
- •1) Other pelvic diseases such as other malignancies, endometriosis, ovarian tumors, acute pelvic disease
- •2) Clinically suspected Sarcoma
- •3) Diffuse adenomyosis in which uterine adenomyoma is spread to the uterus
- •4) In case the pregnancy is positive or the pregnancy is desired
- •5) Severe systemic disease
- •6) Less than 25% of hematocrit
- •7) If there is a wide abdominal scar in the area where the ultrasound light passes
- •8) In case of a surgical clip or scar in the passageway through which a high-strength focused ultrasound passes
- •9) If you can not lie down in a comfortable position
- •10) MRI taboo (including clause phobia)
- •11) Contraindications to MRI contrast agents
- •12) Contraindications to Ultrasound contrast agents
- •13) GFR (glomerular filtration rate) is less than 30 ml / min
- •14) When communication is difficult
- •15) Patients who have participated in other clinical trials within the last month
- •16) Others, if judged by the investigator to be inappropriate for participation in this trial
研究者
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