Anastomotic Leak Clinical Trial
— CostALOfficial title:
Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.
Status | Recruiting |
Enrollment | 215 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Male or Female - Subject understands and has voluntarily signed and dated the informed consent form (ICF). - Subjects must be willing to comply with trial requirements - Subject has performed an open or laparoscopic surgery with peritoneal or pelvic drainage Exclusion Criteria: - Subject is pregnant - Subject will be discharged < 8 hours post-surgery - 24 or more have passed since the end of the subject's surgery - Involvement in the planning and conduct of the clinical investigation - Subject is allergic to contrast medium - Participation in another investigational drug or device study which would interfere with the endpoints of this study - Device does not attach to drain used on the subject |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital - Hamilton Health Sciences | Hamilton | Ontario |
Canada | Juravinski Hospital- Hamilton Health Sciences | Hamilton | Ontrario |
Lead Sponsor | Collaborator |
---|---|
FluidAI Medical | Hamilton Health Sciences Corporation, Ontario Bioscience Innovation Organization |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Does Stream™ Platform integrate well with the existing clinical workflow (1)? | Quantify average time spent by clinical research coordinator (CRC)/delegate interacting with Stream™ Platform (during attachment, daily calibration, and detachment) in minutes | Through study completion, an average of 1 year | |
Primary | Does Stream™ Platform integrate well with the existing clinical workflow (2)? | Observe overall compliance to Instructions for use though quantification of the number of daily calibrations completed | Through study completion, an average of 1 year | |
Primary | Does Stream™ Platform integrate well with the existing clinical workflow (3)? | Quantify the overall reported satisfaction score of the CRC/delegate through surveys. | Through study completion, an average of 1 year | |
Primary | Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)? | Quantify the average number of tests and procedures performed to detect anastomotic leakage before and after the implementation of Stream™ Platform. | Upon study completion (12 months) | |
Primary | Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)? | Quantify the average patient cost/cost of hospitalization and by-department cost (log of all billed items including medications, laboratory investigations, diagnostic/radiology investigations, hospital length of stay, ICU admission, re-admission within 30 days after discharge, time of discharge and therapeutic services) for colorectal, HPB, and trauma and acute care patients before and after the implementation of Stream™ Platform. | Upon study completion (12 months) | |
Primary | Number of Subjects with Device Related Adverse Events | An adverse event assessment will be performed in accordance to ISO 14155 standards to determine the number of device related adverse events. | Upon study completion (12 months) | |
Secondary | Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (1)? | Quantify the average time to detect anastomotic leakage after colorectal, HPB, and trauma and acute care patients using conventional diagnostic techniques (PRE) and after the implementation of Stream™ Platform (POST). | Upon study completion (12 months) | |
Secondary | Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (2)? | Quantify the average sensitivity, specificity, and overall accuracy of conventional diagnostic techniques for detection of anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries in contrast to the average sensitivity, specificity, and overall accuracy of Stream™ Platform. | Upon study completion (12 months) | |
Secondary | Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (1)? | a. Quantify the average rate of type of re-intervention due to anastomotic leakage after colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform. | Upon study completion (12 months) | |
Secondary | Does Stream™ Platform reduce the need for non-conservative management and hospital re-admission that is associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries (2)? | Quantify the average number of emergency re-admissions within 30 days after discharge due to anastomotic leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform. | Upon study completion (12 months) | |
Secondary | Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries? | Quantify the average number of adverse events (such as rate of secondary postoperative complications, rate of permanent stoma, 30-day mortality, etc.) due to anastomotic leakage after leakage in colorectal, HPB, and trauma and acute care surgeries before and after the implementation of Stream™ Platform. | Upon study completion (12 months) |
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