NCT00549159Unknown4 期
Multicenter Randomized Clinical Trial to Evaluate the Safety and Effectiveness of Cavaterm TM Thermal Balloon Endometrial Ablation in Women With Dysfunctional Uterine Bleeding Compared to Transcervical Resection of the Endometrium (TCRE)
Pnn Medical A/S2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
研究概览
简要总结
The purpose of study is to compare the treatment success in the study groups.
详细描述
Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willingness and adequate mental capacity to sign written, informed consent
- •Willingness to adhere to study plan regarding control visits and recording of PBLAC
- •> 30 years old
- •Pre-menopausal as determined by FSH ≤30
- •Agree not to use hormonal contraception or any other intervention for bleeding during study
- •Suitable for local and/or general anesthesia
- •A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy
- •Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm.
排除标准
- •Presence of bacteriaemia, sepsis, or other active systemic infection
- •Active pelvic inflammatory disease
- •Clotting defects or bleeding disorders
- •Unwillingness to use a non-hormonal birth control post-ablation
- •Desire for future fertility
- •Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as < 2 cm are in this context not considered abnormal.
- •Any condition leading to possible uterine wall weakness with total wall thickness < 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured.
- •Premalignant or malignant uterine condition within the last five years as confirmed by histology
- •Pregnancy
- •Cervical length > 6 cm.
- •Uterine cavity >30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures).
- •Previous ablation or subtotal hysterectomy
结局指标
主要结局
Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75
时间窗: 12 months
次要结局
- SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment(12 months)
研究者
研究点 (2)
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