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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in pH of Peritoneal Fluid
Timeframe: A clinical model of change in pH over time will be established once the study is completed (up to 18 months)
Change in Electrical Conductivity of Peritoneal Fluid
Timeframe: A clinical model of change in electrical conductivity over time will be established once the study is completed (up to 18 months)
Number of Subjects with Device Related Adverse Events
Timeframe: The total number of device related adverse events will be established once the study is completed (up to 18 months)