NCT03937401Unknown4 期
Use of Oxytocin in MRI-HIFU Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- UFS-Qol
研究概览
简要总结
Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing MRI-HIFU -treatment
- •Patients assessed for suitability to MRI-HIFU treatment
- •willingness to participate in trial
排除标准
- •Known allergy to Syntocinon/oxytocin
- •Elevated blood pressure
- •ischemic heart disease
- •Long QT- interval
研究组 & 干预措施
Patients treated with oxytocin during MRI-HIFU
Experimental
干预措施: Oxytocin (Drug)
结局指标
主要结局
UFS-Qol
时间窗: 12 months after HIFU treatment
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
NPV
时间窗: up to one year
non perfused volume (percentage of fibroid destroyed)
duration of MRI-HIFU
时间窗: up to one year
duration of MRI-HIFU treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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