Validation of a new platform for monitoring pH in abdominal drainage fluid
Official title: Analytical Validation of Stream™ Platform - Sample Collection Protocol
Run by FluidAI Medical · NCT06541431 · Data updated 2026-11-12
This study is testing a new device that checks the acidity of fluid from the abdomen after surgery to see if it can help spot problems early in patients.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | FluidAI Medical Industry-sponsored |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | November 19, 2024 |
| Main results expected | June 2025 |
| Study ends | July 2025 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06541431 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have undergone open or laparoscopic gastrointestinal surgery with abdominal drainage.
✕Probably not a fit
Patients expected to be discharged less than 8 hours post-surgery or those with known infectious diseases affecting the gastrointestinal tract may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the analytical validation of the Stream™ Platform, which includes the Origin™ inline biosensor system designed for real-time monitoring of pH levels in abdominal drainage fluid after gastrointestinal surgery. The study will assess the precision, linearity, and analytical specificity of pH measurements taken by the Origin™ device using both calibration fluids and actual patient samples. It aims to establish the reliability of this technology in detecting postoperative complications through accurate monitoring of drainage fluid characteristics. The study will involve multiple centers and will collect daily samples from eligible patients undergoing specific types of surgeries.
Why it matters
Potential benefit: If successful, this platform could significantly enhance postoperative monitoring, leading to earlier detection of complications and improved patient outcomes.
How similar studies have gone: While this approach is innovative, similar studies focusing on real-time monitoring of physiological parameters have shown promise in improving patient care.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Juravinski Hospital
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Dr Pablo Serrano, MD MPH FACS — Juravinski Hospital - Hamilton Health Sciences
- Study coordinator: Dr Pablo Serrano, MD MPH FACS
- Email: serrano@mcmaster.ca
- Phone: (905) 521-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.