- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05994625
Economic Evaluation of Stream™ Platform (CostAL)
Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Dr. Pablo E Serrano, MD, MPH, FACS
- Phone Number: 43872 (905) 521-2100
- Email: serrano@mcmaster.ca
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Not yet recruiting
- Hamilton General Hospital - Hamilton Health Sciences
-
Contact:
- Dr. Edward Passos, MD, FRCSC
- Phone Number: 44237 905-521-2100
- Email: passosem@mcmaster.ca
-
-
Ontrario
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Hamilton, Ontrario, Canada, L8V 1C3
- Recruiting
- Juravinski Hospital- Hamilton Health Sciences
-
Contact:
- Dr. Pablo E Serrano, MD, MPH, FACS
- Phone Number: 43872 (905) 521-2100
- Email: serrano@mcmaster.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group.
The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid.
The continuous pH and electrical conductivity measurements will be used to calculate a Risk Score that will be provided to surgeons.
Surgeons will employ the Risk Score produced alongside the standard of care for guiding the postoperative care of patients.
|
Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor). Stream™ Platform utilizes the continuous measurements of drain effluent characteristics to generate a Risk Score that is provided to the surgeon. The Risk Score is intended to provide an additional tool for the early diagnosis of anastomotic leakage. |
Sham Comparator: Control Group
Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group.
The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid.
However, Stream™ Platform will not generate a Risk Score and therefore, will not impact the postoperative care of patients.
All procedures will be conducted as per the standard of care or institutional policies.
Stream™ Platform will only be used for observation in the Control group.
|
Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor). This version of Stream™ Platform is utilized purely for observational purposes. Therefore, no Risk Score is generated. This allows postoperative monitoring of patients without any influence from the Stream™ Platform.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does Stream™ Platform integrate well with the existing clinical workflow (1)?
Time Frame: Through study completion, an average of 1 year
|
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
|
Does Stream™ Platform integrate well with the existing clinical workflow (2)?
Time Frame: Through study completion, an average of 1 year
|
Observe overall compliance to Instructions for use though quantification of the number of daily calibrations completed
|
Through study completion, an average of 1 year
|
Does Stream™ Platform integrate well with the existing clinical workflow (3)?
Time Frame: Through study completion, an average of 1 year
|
Quantify the overall reported satisfaction score of the CRC/delegate through surveys.
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Through study completion, an average of 1 year
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Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (1)?
Time Frame: Upon study completion (12 months)
|
Quantify the average number of tests and procedures performed to detect anastomotic leakage before and after the implementation of Stream™ Platform.
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Upon study completion (12 months)
|
Does Stream™ Platform reduce the cost of care for anastomotic leak patients in colorectal, hepatobiliary, and trauma and acute care surgeries (2)?
Time Frame: Upon study completion (12 months)
|
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.
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Upon study completion (12 months)
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Number of Subjects with Device Related Adverse Events
Time Frame: Upon study completion (12 months)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)?
Time Frame: Upon study completion (12 months)
|
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).
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Upon study completion (12 months)
|
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)?
Time Frame: Upon study completion (12 months)
|
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.
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Upon study completion (12 months)
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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)?
Time Frame: Upon study completion (12 months)
|
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.
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Upon study completion (12 months)
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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)?
Time Frame: Upon study completion (12 months)
|
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.
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Upon study completion (12 months)
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Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?
Time Frame: Upon study completion (12 months)
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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.
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Upon study completion (12 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS0007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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