JPRN-C000000039已完成1 期
A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302) - Uterine artery embolization using gelatine sponge for uterine leiomyoma (JIVROSG-0302)
Japan Interventional Radiology in Oncology Study Group (JIVROSG)0 个研究点目标入组 33 人开始时间: 2005年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
Technical success was achieved in all patients. -Median follow-up period was 33 months. -Minor AEs occurred in 10 pts (33%) and major AEs in two (6%). The most common AE was transient amenorrhea. -Median hospital stay was five days. -The rates of symptom improvement at 12 months were: menorrhagia, 90%; pelvic pain,77%;bulk-related symptoms, 96%. -The mean reduction rate in leiomyoma volume on MRI at 12 month was 61%. : Presented at SIR 2008, Washington D.C.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable(—)
- 性别
- Female
入选标准
- 未提供
排除标准
- •1) Pregnant, nursing, or desiring future pregnancy. 2) Active pelvic inflammatory disease. 3) Pelvic malignancy. 4) Previous hormonal therapy within 12 weeks. 5) Contraindication to MRI. 6) Contraindication to iodized contrast material. 7) Uncontrolled cardiac, respiratory, gastrointestinal, or nervous disorders. Uncontrolled diabetes, hypertension, or infection. 8) Adenomyosis confirmed with MRI.
研究者
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