Validation Study of Stream Platform for Real-Time pH Monitoring in Abdominal Drainage Fluid After Gastrointestinal Surgery

What this Trial Is About

Researchers are evaluating the Stream Platform, which includes the Origin inline biosensor system, for accurately monitoring the pH of abdominal drainage fluid in patients after gastrointestinal surgery. This study aims to validate the analytical performance of the Origin device, including its precision, linearity, specificity, and how well it compares to standard laboratory methods. The study involves patients who have undergone colorectal, hepatobiliary, trauma, or acute care surgeries and have abdominal drains in place. The study collects abdominal drainage fluid samples daily from patients until their hospital discharge or drain removal, as determined by their surgeon. These samples, along with commercially available calibration fluids and simulated peritoneal fluids, will be used to test and verify the accuracy and reliability of the pH measurements by the Origin system. The study also includes evaluation of novel features of the Origin device designed to improve user workflow. Participants will have samples collected daily without any additional risk, as the fluid is normally discarded after surgery. No personal health information is collected, and no follow-up is required after discharge or drain removal. The research team will assess the devices measurement traits over an 8-month period, including testing for precision, linearity, specificity, and method comparisons. The total participation lasts until the patient is discharged or the drain is removed.

Analytical Validation of Stream™ Platform