Collaboration Live Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Rate of Clinically Acceptable Performance of Remote Control Functionality
研究概览
简要总结
Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Subject is at least 18 years of age
- •Subject in indicated for a routine Obstetrics/Gynecology ultrasound examination at the site.
- •Subject is willing and capable of providing informed consent and participating in this study
排除标准
- •A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
结局指标
主要结局
Rate of Clinically Acceptable Performance of Remote Control Functionality
时间窗: Intra-procedural (1 day)
The system responds to the remote input as intended and without a delay interfering with the conduct of the exam. Additionally, a clinically acceptable exam would result in no adverse events related to the control feature
次要结局
- Number of Participants With Technical Issues(Intra-procedural (1 day))
- Travel Reduction Attributable to Use of Collaboration Live(Intra-procedural (1 day))
- Ease of Use(Intra-procedural (1 day))
- User Feedback Regarding Streaming, Image Quality and Overall Experience(Intra-procedural (1 day))
- Patient Feedback Regarding Remote Consultation(1 day)
- Impact of Remote Consultation on Reimbursement(30 days)
- Success Rates for Key Tasks in the Collaborative Exam(Intra-procedural (1 day))