NCT01539187终止不适用
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
Gynesonics20 个研究点 分布在 3 个国家目标入组 6 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 20
- 主要终点
- Mean percentage change in target fibroid perfused volume
研究概览
简要总结
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •28 years of age or older
- •Consistent menstrual cycles
- •History of excessive bleeding for at least 3 months
- •Baseline UFS-QOL Symptom severity score ≥ 20
- •At least one target fibroid having a maximum diameter > 5cm and ≤ 10 cm
- •Not at material risk for pregnancy
- •Willingness to participate, adhere to follow-up requirements, and sign the informed consent form
- •Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents
- •Menstrual Pictogram score ≥ 120 during a one-month screening period.
排除标准
- •Presence of type 0 intracavitary fibroids
- •Target fibroid > 10cm in maximum diameter
- •Abnormality of the endometrial cavity that obstructs access of the treatment device
- •Postmenopausal
- •Desire for current or future fertility
- •Hemoglobin < 6 g/dl
- •Evidence of disorders of hemostasis
- •Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening
- •Evidence for current cervical dysplasia (CIN II or greater)
- •Endometrial hyperplasia
- •Confirmed abdominal / pelvic malignancy within previous five years
- •Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia
- •Clinically significant adenomyosis
- •Previous uterine artery embolization
- •Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening
- •Current use of anticoagulant therapy
- •Major medical or psychiatric illness affecting general health or ability to adhere to follow-up
- •Contraindication to MRI
- •Renal insufficiency
- •Uncontrolled hypertension lasting 2 years or more
- •Calcified fibroids
- •Presence of extrauterine pelvic mass
- •Presence of tubal implant for sterilization
- •Previous pelvic irradiation
- •Endometrial cavity length < 4.5 cm
结局指标
主要结局
Mean percentage change in target fibroid perfused volume
时间窗: Baseline, 3 months, 12 months
次要结局
- Number of adverse events(Procedure through 12 mo)
- Percentage reduction in Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire(Baseline through 12 months)
- Rate of surgical reintervention for menorrhagia(through 12 months)
- Return to normal daily activity(2 weeks or until returned to normal activity)
- Percentage reduction in Menstrual Pictogram score(through 12 months)
研究者
研究点 (20)
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