Status:
RECRUITING
Analytical Validation of Stream™ Platform
Lead Sponsor:
FluidAI Medical
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Gastrointestinal Diseases
Eligibility:
All Genders
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 abdom...
Detailed Description
This is a multi-center study, being conducted to facilitate the Analytical Validation of Stream™ Platform. This includes precision evaluation assessing repeatability and reproducibility of the pH meas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06541431
Start Date
November 19 2024
End Date
July 1 2025
Last Update
March 12 2025
Active Locations (1)
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1
Juravinski Hospital
Hamilton, Ontario, Canada, L8V1C3