NCT04298268已完成不适用
Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Effectiveness of soft tissue removal per surgeon assessment.
研究概览
简要总结
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures. This will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery
- •Subject is an appropriate candidate to receive use of the CUSA® Clarity Ultrasonic Surgical Aspirator System product for soft tissue removal during surgery, per the study surgeon
- •Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable.
排除标准
- •Subject is currently pregnant or plans to become pregnant prior to the study index surgery
- •Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
- •Subject's surgical plan includes utilizing CUSA® Clarity Ultrasonic Surgical Aspirator System for the removal of uterine fibroids
- •Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.
- •Intra-operative exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.
结局指标
主要结局
Effectiveness of soft tissue removal per surgeon assessment.
时间窗: During the surgery
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
次要结局
未报告次要终点
研究者
研究点 (5)
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