Analytical Validation of Stream™ Platform
NCT Number: NCT06541431
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastrointestinal Diseases
Interventions: OTHER: Abdominal Drainage Fluid Collection
Sponsor: FluidAI Medical
Collaborators: Hamilton Health Sciences Corporation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-04

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.

Primary Outcome Measures: Conduct precision evaluation of pH measurements obtained using Origin™, The objective of these tests is to assess the ability of the Origin™ to provide a measurement proportional to the measurand being quantified over a defined range of pH with acceptable levels of variance, such that the device meets predefined acceptance criteria for precision estimates., 8 months|Evaluate the linearity of pH measurements obtained using Origin™, The objective of this test is to establish, verify and demonstrate the linear range of Origin™ in measuring the pH of peritoneal fluid., 8 months|Evaluate the Analytical Specificity of pH measurements obtained using Origin™, The objective of this test is to evaluate the effect of potential interfering substances on the clinical and analytical performance of the Origin™ via paired difference testing. In the event of an interference effect a dose-response experiment will be conducted to determine the magnitude of interference as a function of interferent concentration., 8 months|Conduct method comparison studies for measuring pH of abdominal drainage fluid, The objective of this test is to compare the pH measurements of abdominal drainage fluid using Origin™ and a standard benchtop comparator., 8 months
Secondary Outcome Measures: Testing, verification of validation of new Origin™ features, To utilize samples of abdominal drainage for testing, verification and validation of new features developed to optimize the user workflow of Origin™ in hospitals., 8 months