Recruiting

Observational Study

Sponsor:

FluidAI Medical

Code:

NCT06541431

Conditions

Gastrointestinal Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Abdominal Drainage Fluid Collection

Study Details

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

Study ID

NCT06541431

Start date

Nov 19, 2024

Status verified date

Mar, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Abdominal 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.

Primary outcome measure

  • Conduct precision evaluation of pH measurements obtained using Origin™ [ Time Frame: 8 months ]
  • Evaluate the linearity of pH measurements obtained using Origin™ [ Time Frame: 8 months ]
  • Evaluate the Analytical Specificity of pH measurements obtained using Origin™ [ Time Frame: 8 months ]
  • Conduct method comparison studies for measuring pH of abdominal drainage fluid [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Dr Pablo Serrano, MD MPH FACS

(905) 521-2100serrano@mcmaster.ca

Locations

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V1C3

Contacts

Allen Lian

905-962-1588lianz1@mcmaster.ca

Elisabeth Lo

loe3@mcmaster.ca

Principal Investigator:

Dr Pablo Serrano, MD, MSc, MPH

More Information

Sponsor

FluidAI Medical

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by FluidAI Medical on 2025-03-12.