NCT03915717终止不适用
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
研究概览
简要总结
The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.
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
- •Age > 18 years
- •Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
- •Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
- •Women of childbearing potential have a negative pregnancy test
排除标准
- •Age <18 years old
- •Patient unable to sign informed consent
- •Patient participating in another investigational device or pharmacological study
- •Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
结局指标
主要结局
Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
时间窗: Through study completion
Surgeon evaluation of improved monitoring ability via questionnaire with likert scale
Surgeon Evaluation of Satisfaction
时间窗: Through study completion, an average of 1 year
Surgeon evaluation of satisfaction via questionnaire with likert scale
次要结局
- Flap Failure Rate(Through patient stay, up to 5 days post-op)
- Flap Takeback Rate(Through patient stay, up to 5 days post-op)
- Flap Salvage Rate(Through patient stay, up to 5 days post-op)
- Total Cost of Hospitalization(Through patient stay, up to 5 days post-op)
- Time From OR Departure to Return to OR(Through patient stay, up to 5 days post-op)
- Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale(Through study completion, an average of 1 year)
研究者
研究点 (1)
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