NCT06541431 Analytical Validation of Stream™ Platform
| NCT ID | NCT06541431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FluidAI Medical |
| Condition | Gastrointestinal Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-11-19 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Dr Pablo Serrano, MD MPH FACS
PRINCIPAL INVESTIGATOR
Juravinski Hospital - Hamilton Health Sciences
Frequently Asked Questions
Who can join the NCT06541431 clinical trial?
This trial is open to participants of all sexes, studying Gastrointestinal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541431 currently recruiting?
Yes, NCT06541431 is actively recruiting participants. Contact the research team at serrano@mcmaster.ca for enrollment information.
Where is the NCT06541431 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT06541431 clinical trial?
NCT06541431 is sponsored by FluidAI Medical. The principal investigator is Dr Pablo Serrano, MD MPH FACS at Juravinski Hospital - Hamilton Health Sciences. The trial plans to enroll 50 participants.