Analytical Validation of Stream™ Platform

NCT06541431 | Recruiting

• 1 other identifier: CLS0012
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (4)

• Conduct precision evaluation of pH measurements obtained using Origin™

  The objective of these tests is to assess the ability of the Origin™ to provide a measurement proportional to the measurand being quantified over a defined range of pH with acceptable levels of variance, such that the device meets predefined acceptance criteria for precision estimates.

  8 months

• Evaluate the linearity of pH measurements obtained using Origin™

  The objective of this test is to establish, verify and demonstrate the linear range of Origin™ in measuring the pH of peritoneal fluid.

  8 months

• Evaluate the Analytical Specificity of pH measurements obtained using Origin™

  The objective of this test is to evaluate the effect of potential interfering substances on the clinical and analytical performance of the Origin™ via paired difference testing. In the event of an interference effect a dose-response experiment will be conducted to determine the magnitude of interference as a function of interferent concentration.

  8 months

• Conduct method comparison studies for measuring pH of abdominal drainage fluid

  The objective of this test is to compare the pH measurements of abdominal drainage fluid using Origin™ and a standard benchtop comparator.

  8 months

Secondary Outcomes (1)

• Testing, verification of validation of new Origin™ features

  8 months

Study Arms (1)

Sample Collection Cohort

This group will contain patients that undergo gastrointestinal surgeries, namely hepatobiliary, colorectal, trauma, and acute care procedures, and received an abdominal drain. Samples of abdominal drainage fluid will be collected daily from each patient.

Other: Abdominal Drainage Fluid Collection

Interventions

Abdominal Drainage Fluid Collection OTHER

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.

Sample Collection Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FluidAI Medical: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V1C3, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This study will focus on the collection of abdominal drainage fluid from study subjects. Subjects that undergo gastrointestinal surgery often receive a prophylactic intra-peritoneal or pelvic drain. This drain prevents buildup of fluid in the abdominal cavity after surgery. The fluid from the drain is collected in an evacuator. The fluid may be used in laboratory, or is typically discarded. This fluid will be collected daily in this study. The fluid may contain DNA.

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Dr Pablo Serrano, MD MPH FACS

  Juravinski Hospital - Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Pablo Serrano, MD MPH FACS

CONTACT

(905) 521-2100; serrano@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: November 19, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)