Analytical Validation of Stream™ Platform
ConditionGastrointestinal Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFluidAI Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 performed an open or laparoscopic surgery with abdominal/ pelvic drainage
Disqualifiers
Subject is expected to be discharged less than 8 hours post-surgery
Subject carries has a known infectious disease such as Hepatitis B or C, HIV, TB, infections caused by multi-drug resistant organisms, or known parasitic infections affecting the gastrointestinal tract
Involvement in the planning and conduct of the clinical investigation
Trial population
Subjects included in this study will consist of several patient populations who have undergone abdominal surgery and received an abdominal drain. This includes colorectal, hepatobiliary, and trauma and acute care patients. All subjects must meet the inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Abdominal Drainage Fluid Collection
Other interventionAbdominal drainage fluid will be collected daily from the subjects until they are discharged from the hospital, or their abdominal/pelvic drain is removed, as determined by the treating surgeon.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Sample Collection Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 months2
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.
Time frame
8 months3
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.
Time frame
8 months4
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.
Time frame
8 monthsSecondary outcomes
1
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.
Time frame
8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FluidAI Medical
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Source ClinicalTrials.gov