Clinical Research Directory

Analytical Validation of Stream™ Platform

Sponsor: FluidAI Medical

Summary

The accurate monitoring of physiological parameters in postoperative patients is essential for early detection and management of potential complications. One such critical parameter is the pH of abdominal drainage fluid, which can provide valuable insights into the patient's recovery and the presence of any postoperative infections or complications after gastrointestinal surgery. The Stream™ Platform, consisting of the Origin™ inline biosensor system and supporting materials, represents a significant advancement in this area. Origin™ is designed to be integrated inline with a standard surgical drain, enabling real-time monitoring of drainage effluent characteristics, specifically pH, which represents the acidity of the fluid. This protocol details the analytical validation of the Stream™ Platform, focusing on the pH measurements conducted by the Origin™ device. The study aims to establish the precision, linearity, and analytical specificity of the Origin™ system. Additionally, method comparison studies will be conducted to evaluate the performance of the Origin™ device against standard bench-top comparators. The multi-center study will be conducted using commercially available calibration fluids and abdominal drainage samples collected from patients undergoing abdominal surgeries. These samples, which include those from colorectal, hepatobiliary, and trauma and acute care patients, will be utilized to validate the Origin™ device's capability to deliver accurate and reliable pH measurements.

Official title: Analytical Validation of Stream™ Platform - Sample Collection Protocol

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