Gastrointestinal DiseasesNCT06541431
Analytical Validation of Stream™ Platform
An observational study of Gastrointestinal Diseases, run by FluidAI Medical at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Abdominal Drainage Fluid Collection
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2024to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Hospital
Hamilton, Ontario, L8V1C3
Allen Lian, 905-962-1588, lianz1@mcmaster.ca
Elisabeth Lo, loe3@mcmaster.ca
About this study
Official title: Analytical Validation of Stream™ Platform - Sample Collection Protocol
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.
Read the 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.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Abdominal Drainage Fluid Collection
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Drainage Fluid CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Abdominal Drainage Fluid Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (1)
Testing, verification of validation of new Origin™ features
To utilize samples of abdominal drainage for testing, verification and validation of new features developed to optimize the user workflow of Origin™ in hospitals.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start19 Nov 2024
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FluidAI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Dr Pablo Serrano, MD MPH FACS, Principal investigator, Juravinski Hospital - Hamilton Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541431
- Sponsor's protocol ID
- CLS0012
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Validation of Stream™ Platform - Sample Collection Protocol
- ClinicalTrials.gov ID
- NCT06541431
- Acronym / sponsor ID
- CLS0012
- Conditions
- Gastrointestinal Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FluidAI MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample Collection Cohort | – | Other: Abdominal Drainage Fluid CollectionThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Drainage Fluid CollectionAbdominal 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. | Other | Sample Collection Cohort |
Primary outcome
Conduct precision evaluation of pH measurements obtained using Origin™
Time frame: 8 months
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.
Evaluate the linearity of pH measurements obtained using Origin™
Time frame: 8 months
The objective of this test is to establish, verify and demonstrate the linear range of Origin™ in measuring the pH of peritoneal fluid.
Evaluate the Analytical Specificity of pH measurements obtained using Origin™
Time frame: 8 months
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.
Conduct method comparison studies for measuring pH of abdominal drainage fluid
Time frame: 8 months
The objective of this test is to compare the pH measurements of abdominal drainage fluid using Origin™ and a standard benchtop comparator.
1 secondary outcome
Testing, verification of validation of new Origin™ features
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Pablo Serrano, MD MPH FACS principal investigator
Juravinski Hospital - Hamilton Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by FluidAI Medical at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Pablo Serrano, MD MPH FACS ((905) 521-2100 ext. 43872, serrano@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conduct precision evaluation of pH measurements obtained using Origin™ (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.