Use of NERv's Inline Device for the Continuous Monitoring of pH and Conductance Measurements as an Early Diagnostic Method for Anastomotic Leak.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in pH of Peritoneal Fluid
研究概览
简要总结
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical post-operative anastomotic/intraperitoneal leakages.
NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.
The purpose of NERv's feasibility clinical trial is to collect pH and conductance readings by analyzing peritoneal drainage fluid. Upon analyzing data collected from NERv's Inline Device a clinical model of pH and conductance will be created. The clinical model can then be used to determine if a complication is developing. For instance, boundaries (reading thresholds) can be established where if the signal goes outside the boundaries a complication could be identified. Specifically the ability to detect a post-operative complication known as anastomotic leakage; which is a dreaded complication associated with abdominal surgeries; will be the main focus of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
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 attached post-surgery
排除标准
- •Plans that the subject will be discharged 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 would interfere with the endpoints and follow-ups of this study
- •Subject is consuming steroid or anti-inflammatory medication
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 28 weeks).
NERv's Inline Device will be collecting continuous pH measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Conductance of Peritoneal Fluid
时间窗: A clinical model of change in conductance over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous conductance measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Change in Temperature of Peritoneal Fluid
时间窗: A clinical model of change in temperature over time will be established once the study is completed (up to 28 weeks).
NERv's Inline Device will be collecting continuous temperature measurements of fluid that travels across the peritoneal drain of bariatric surgery patients.
Number of Subjects with Device Related Adverse Events
时间窗: The number of device related will be established once the study is completed (up to 28 weeks).
an adverse event assesmtent will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events.
次要结局
- Investigator and Subject Feedback on Device's Ease of Use and Comfort level(Overall comfort level and ease of use will be established once the study is completed (up to 28 weeks).)