RecruitingNCT06541431

Analytical Validation of Stream™ Platform

Analytical Validation of Stream™ Platform - Sample Collection Protocol

Sponsor

FluidAI Medical

Enrollment

50 participants

Start Date

Nov 19, 2024

Study Type

OBSERVATIONAL

Conditions

Gastrointestinal Diseases

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

Inclusion Criteria4

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 Criteria3

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

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Interventions

OTHERAbdominal Drainage Fluid Collection

Abdominal 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.