NCT00768742撤回不适用
Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores
Gynesonics6 个研究点 分布在 1 个国家开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
研究概览
简要总结
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal
- •Regular, consistent menstrual cycles
- •Serum progesterone > 6 ng/ml (19 nmol/L)
- •2 months history of PBLAC score of 150-500
- •Maximum of 4 type I, type II, or intramural fibroids
- •Patient is at low risk for cervical cancer
- •Hemoglobin > 6 g/dl
- •Not at risk for pregnancy
- •No desire for future fertility
- •Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
- •Willing to sign a consent form
排除标准
- •Subserosal fibroids.
- •Any fibroid that obstructs access to the endometrial cavity
- •FSH > 20 IU/L
- •Pregnancy
- •Evidence of disorders of hemostasis
- •Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
- •SERMS/SPRMS within the last 6 months
- •Current use of any IUD or use of Mirena IUS within the last 3 months
- •Gynecological malignancy or hyperplasia
- •Known/suspected abdominal/pelvic cancer
- •Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
- •Adenomyosis
- •Previous surgical or ablative treatment for fibroids or menorrhagia
- •Previous uterine artery embolization or occlusion
- •Patient on anti-coagulation therapy
- •Needing emergency surgery to treat fibroid symptoms
- •Concomitant intrauterine polyps.
- •Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data
- •Contraindication to MRI
- •Allergy to contrast media
- •Mild renal insufficiency or worse
- •Known renal disease
- •Uncontrolled hypertension lasting 2 years or more
- •Uterine size > 10 weeks or 10 cm from ectocervix to fundus.
结局指标
主要结局
Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
时间窗: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
次要结局
- Quality of Life questionnaires(Baseline, 3 mo, 6 mo, 9 mo, 12 mo)
- Rate of surgical reintervention(12 mo)
- Adverse events(At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.)
- Subject tolerance of procedure rated via analog visual scale(Discharge)
- Fibroid dimension and non-perfused volume(Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo)
- Pregnancy and pregnancy-related complications(3 mo, 6 mo, 9 mo, and 12 mo)
- Time required to return to normal daily activity(7-14 days)
研究者
研究点 (6)
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