NCT01226290终止不适用
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
Gynesonics20 个研究点 分布在 3 个国家目标入组 51 人开始时间: 2011年1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
- 51
- 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 primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating 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
- •Regular, consistent menstrual cycles
- •History of excessive bleeding
- •One Menstrual Pictogram score ≥ 120 during a one-month screening period
- •Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
- •Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc
- •At least one fibroid must indent the endometrium
- •Subject is not at material risk for pregnancy.
- •Subject is willing to maintain use or non-use of hormonal contraception
- •Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents
排除标准
- •Subserosal fibroids with bulk symptoms
- •Presence of type 0 intracavitary fibroids
- •Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
- •Any fibroid that obstructs access of the VizAblate probe
- •Postmenopausal by history
- •Desire for current or future fertility
- •Hemoglobin < 6 g/dl
- •Pregnancy
- •Evidence of disorders of hemostasis
- •Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM)
- •Short-term use of hormonal medication for management of bleeding
- •Evidence for current cervical dysplasia
- •Endometrial hyperplasia
- •Confirmed abdominal / pelvic malignancy within the previous five years
- •Active pelvic infection
- •Clinically significant adenomyosis
- •Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months
- •Current use of anticoagulant therapy
- •Need for emergency surgery to treat fibroid symptoms
- •Concomitant intrauterine polyps > 1.0 cm
- •Contraindication to MRI
- •Renal insufficiency
- •Uncontrolled hypertension lasting 2 years or more
- •One or more treatable fibroids that are calcified
- •Chronic pelvic pain
- •Presence of an extrauterine pelvic mass
- •Presence of a 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: 3 months
次要结局
- Number of adverse events(procedure through 12 mo)
- Percentage reduction in Menstrual Pictogram score(baseline through 12 months)
- Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire(baseline through 12 months)
- Return to normal daily activity(2 weeks or until returned to normal activity)
- Rate of surgical reintervention for menorrhagia(through 12 months)
研究者
研究点 (20)
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