NCT00574418Unknown1 期
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids
GAAD Medical Research Institute Inc.2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
研究概览
简要总结
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.
详细描述
Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid.
We are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18 or older with symptomatic fibroids
排除标准
- •Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
- •Metallic implants that are incompatible with MRI or ultrasound
- •Known intolerance to the MRI contrast agent (e.g. Gadolinium)
结局指标
主要结局
The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
时间窗: 2 years and 9 months
次要结局
- The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related uterine conditions, for example, bleeding.(Two years and nine months)
研究者
研究点 (2)
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