Analytical Validation of Stream™ Platform
Recruiting now
Conditions studied: Gastrointestinal Diseases
In brief
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.
Key facts
- Study ID
- NCT06541431
- Run by
- FluidAI Medical
- People needed
- 50
- Starts
- 2024-11-19
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2025-03-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Juravinski Hospital — Hamilton, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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