Clinical trial NCT06541431: Analytical Validation of Stream™ Platform
Official title: Analytical Validation of Stream™ Platform - Sample Collection Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Diseases
Lead sponsor: FluidAI Medical
Sponsor class: INDUSTRY
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2024-08-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects included in this study will consist of several patient populations who have undergone abdominal surgery and received an abdominal drain. This includes colorectal, hepatobiliary, and trauma and acute care patients. All subjects must meet the inclusion and exclusion criteria.

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.

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 measurements conducted by Origin™, tests evaluating the linearity of measurements, analytical specificity (interference testing), and method comparison studies. The tests described under this study will be completed using commercially available calibration fluids, and peritoneal drainage samples collected from patients that undergo gastrointestinal surgery. Simulated peritoneal fluids, adjusted to the required pH may be utilized in some cases. Additionally, peritoneal drainage samples may be used for testing, verification, and validation of novel Origin™features, designed to improve user workflow. The following patient populations will be eligible for the collection of abdominal drainage samples: colorectal, hepatobiliary, and trauma and acute care patients.

This study will require collection of peritoneal drainage fluid of subjects that undergo gastrointestinal surgery. One sample will be collected per day and will be labelled with a study ID, date and time of collection, and then frozen. The sample will be supplied to FluidAI team. The team at FluidAI will conduct the laboratory assessments required for analytical validation of pH measurements of Origin™.

This study does not pose any risk to participants as abdominal drainage fluid is routinely discarded as it is considered a waste product. No personal health information will be collected from the participants, and the study requires no follow up. Participation from subjects will be deemed complete when they are discharged from the hospital, or when their abdominal drain is removed as determined by their surgeon.

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

Primary outcomes:
measure: Conduct precision evaluation of pH measurements obtained using Origin™
timeFrame: 8 months
measure: Evaluate the linearity of pH measurements obtained using Origin™
timeFrame: 8 months
measure: Evaluate the Analytical Specificity of pH measurements obtained using Origin™
timeFrame: 8 months
measure: Conduct method comparison studies for measuring pH of abdominal drainage fluid
timeFrame: 8 months
Secondary outcomes:
measure: Testing, verification of validation of new Origin™ features
timeFrame: 8 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: Juravinski Hospital - Hamilton Health Sciences
name: Dr Pablo Serrano, MD MPH FACS
role: PRINCIPAL_INVESTIGATOR
References: