Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541431
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Analytical Validation of Stream Platform
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analytical Validation of Stream Platform - Sample Collection Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 devices capability to deliver accurate and reliable pH measurements
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 devices 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 Originfeatures 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None