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The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use.
Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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. All subjects recruited will take part in the evaluation of Stream™ Platform in a simulated home-use environment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stream™ Platform | Device | Stream™ Platform consists of 5 main components: Origin™, Delta™ Monitor, Stream™ Application, Accessory Calibration Syringe(s), and Stream™ Cart. Origin™ is an inline biosensor system that can be attached between an off-the-shelf drainage catheter and evacuator bag/bulb system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) for the early identification of postoperative complications. Origin™ requires daily calibration (via Accessory Calibration Syringe(s)) for optimal performance and accuracy of its sensors. 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) that are supplied by FluidAI. Origin connects to Stream Application via Bluetooth. Mobile carts/mounts, denoted Stream™ Carts/Delta Mounts, will be used to house the Delta™ Monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use) |
i. Adverse Device Events (ADE) ii. Serious Adverse Device Events (SADE) iii. Unanticipated Serious Adverse Device Events (USADE) iv. Device Deficiencies | Through study completion, an average of 6-months |
| Evaluate lay users' satisfaction through user feedback survey | Subject reported overall satisfaction with daily calibrations and overall device. The following parameters will be recorded on a scale of 1-5:
| Through study completion, an average of 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Utilize continuous pH and EC measurements collected prospectively using Stream™ Platform to supplement FluidAI's existing clinical model for early prediction of leakage after colorectal surgery. | Data collected will be used to supplement Stream™ Platform's existing clinical model for early prediction of leakage. | Through study completion, an average of 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carl J Brown, BSc MSc MD FRCSC | Contact | 604-682-2344 | cbrown@providencehealth.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital - Providence Healthcare (PHC) | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The investigators, care providers, participants, and outcome assessors will be blinded to the anastomotic leak risk-score generated by Stream Platform. This will ensure that subject care is not influenced by use of the device and postoperative monitoring is conducted as per the standard of care.
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| Identify correlations between measurements from Stream™ Platform and current standard of care (SOC). | Assess if any strong correlations exist between pH/EC measurement collected using FluidAI's Stream™ Platform and other diagnostic biomarkers for AL | Through study completion, an average of 6-months |
| Estimate the time taken by lay users to conduct calibration procedures | Quantify the average time taken by subjects/caregiver to conduct calibration in seconds as measured by the Stream™ Platform | Through study completion, an average of 6-months |