NCT02851953已完成不适用
Effectiveness and Safety Evaluation of Aqueduct -100 Device
Aqueduct Medical Ltd2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
研究概览
简要总结
The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.
The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects, females, 18 years of age or older.
- •Subjects undergoing any process that requires dilation (intrauterine procedures).
- •Subjects understanding the nature of the study and willing to sign informed consent form.
排除标准
- •Subjects younger than 18 years of age.
- •Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis.
- •Subject has been treated with any cervix dilating agent within 2 months before the screening.
- •Known contraindications or hypersensitivity to the components of the investigational product.
- •The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures.
- •Subjects undergoing abortion <7 and >9 weeks of pregnancy.
- •Subjects unwilling to sign the informed consent form.
结局指标
主要结局
Percentage of patients with dilation of cervix to a pre-determined diameter before the intrauterine procedure using Aqueduct-100 device.
时间窗: Through study completion, approximately 9 months
The primary outcome of this study is to determine the effectiveness of the Aqueduct-100 device to dilate the uterine cervices to the desired diameter.
次要结局
- Measurement of physicians' satisfaction with the device, through the use of a questionnaire.(Through study completion, approximately 9 months)
- Occurrence of Adverse Events: rate, list and severity of AEs and SAEs.(Through study completion, approximately 9 months)
- Time frame required to reach desired cervical dilation from start time (insertion of device) to completion of dilation (removal of catheter)(Through study completion, approximately 9 months)
研究者
研究点 (2)
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