Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductivity as an Early Diagnostic Method for Postoperative Complications
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 13
- 主要终点
- Change in pH of Peritoneal Fluid
研究概览
简要总结
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data. The trial is intended to establish the safety of NERv's Inline Device and collect preliminary data to illustrate the change in pH and electrical conductivity during normal postoperative recovery and in the event of a complication.
The purpose of NERv's feasibility study is to establish a clinical model that shows the progressive change in pH and electrical conductivity during a normal post-operative recovery and in the event of an anastomotic leak in colorectal, hepatobiliary (HPB), trauma, and general surgery patients. Upon analyzing data collected from NERv's Inline Device, a clinical model of change in pH and conductivity over time will be created. The clinical model can be used in future stages to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established to detect a complication when readings exceed such boundaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 - male or female
- •Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)
- •Subjects must be willing to comply with trial requirements
- •Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery
排除标准
- •Plans that the subject will be discharged in less than 8 hours post-surgery
- •Involvement in the planning and conduct of the clinical investigation
- •Subject is participating in another investigational drug or device study which may interfere with the endpoints of this study
- •NERv's Inline Device does not attach to drain used on the subject
结局指标
主要结局
Change in pH of Peritoneal Fluid
时间窗: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)
NERv's Inline Device will be collecting continuous pH measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
Number of Subjects with Device Related Adverse Events
时间窗: The total number of device related adverse events will be established once the study is completed (up to 18 months)
An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events
Change in Electrical Conductivity of Peritoneal Fluid
时间窗: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)
NERv's Inline Device will be collecting continuous electrical conductivity measurements of effluent fluid in abdominal surgery patients during normal recovery and in the event of a complication
次要结局
- Estimate the economic benefit of the early detection of anastomotic leaks by contrasting the time of detection using NERv's Inline Device and Standard of Care(The economic benefit of using NERv's Inline Device will be established once the study is completed (up to 18 months))
- Investigator Feedback on Device's Ease of Use(Ease of use and impact on workflow will be established once the study is completed (up to 18 months))
- Subject Feedback on Device's Comfort level(Comfort level will be established once the study is completed (up to 18 months))