Clinical trial NCT05994625: Economic Evaluation of Stream™ Platform
Official title: Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Anastomotic Leak
Lead sponsor: FluidAI Medical
Sponsor class: INDUSTRY
Collaborators: name: Hamilton Health Sciences Corporation
name: Ontario Bioscience Innovation Organization
First posted: 2023-08-16
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Does Stream™ Platform integrate well with the existing clinical workflow (1)?
timeFrame: Through study completion, an average of 1 year
measure: Does Stream™ Platform integrate well with the existing clinical workflow (2)?
timeFrame: Through study completion, an average of 1 year
measure: Does Stream™ Platform integrate well with the existing clinical workflow (3)?
timeFrame: Through study completion, an average of 1 year
measure: Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)?
timeFrame: Upon study completion (12 months)
measure: Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)?
timeFrame: Upon study completion (12 months)
measure: Number of Subjects with Device Related Adverse Events
timeFrame: Upon study completion (12 months)
Secondary outcomes:
measure: 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)?
timeFrame: Upon study completion (12 months)
measure: 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)?
timeFrame: Upon study completion (12 months)
measure: 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)?
timeFrame: Upon study completion (12 months)
measure: 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)?
timeFrame: Upon study completion (12 months)
measure: Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?
timeFrame: Upon study completion (12 months)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital - Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital- Hamilton Health Sciences
state: Ontrario
Study officials:
References: