User-Centered DesignHome-StreamNCT06522061
Evaluating the Effective and Safe Use of Stream™ Platform
A study testing Stream™ Platform in people with User-Centered Design and Anastomotic Leak, run by FluidAI Medical at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- User-Centered Design, Anastomotic Leak, Colorectal Surgery
- What is being tested?
- Stream™ Platform
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years - male or female.
- Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
- Subject underwent colorectal surgery with anastomosis.
- Subjects must be willing to comply with trial requirements.
- Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.
Who cannot join
- Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
- 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
- The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
- Plans that the subject will be discharged in less than 3 days post-surgery.
- Subject has reported that they are pregnant.
- Subject has a permanent end stoma.
Show all 12Show fewer
- Subject is delirious.
- Subject has severe dementia.
- Subject was involved in the planning and conduct of the clinical investigation.
- Origin™ is not compatible with the drain used on the subject.
- Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
- The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Paul's Hospital - Providence Healthcare (PHC)
Vancouver, British Columbia, V6Z 1Y6
Carl J Brown, BSc MSc MD FRCSC, 604-682-2344, cbrown@providencehealth.bc.ca
Elizabeth Clement, BSc MSc MD FRCSC, eclement1@providencehealth.bc.ca
About this study
Official title: Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment
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.
- Being tested
- Stream™ Platform
- Keywords
- Anastomotic Leak, Artificial Intelligence, Colorectal Surgery, ERAS, Stream Platform
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stream™ PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stream™ Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)
- Statistical evaluation of the number of calibration errors encountered due to lay user error as reported by the healthcare providers.
- Statistical evaluation of the number of calibration errors due to lay user errors that required intervention by the supervising healthcare provider to protect subject health and safety.
- Occurrence of device associated adverse events including:
- Adverse Device Events (ADE) ii. Serious Adverse Device Events (SADE) iii. Unanticipated Serious Adverse Device Events (USADE) iv. Device Deficiencies
Measured: 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:
- System Related Feedback
- Overall feedback on Stream Platform
- Overall feedback on Stream Application
- Training Related Feedback
- Overall feedback on the instructions provided by Stream Application
- Overall feedback on the training material provided including but not limited to training video, infographic, etc.
- Overall feedback on the in-person training conducted
- Subject Comfort Assessment
- Overall subject experience performing ADLs (Activities of Daily Living) while Stream Platform is in use.
- Overall subject experience sleeping while Stream Platform is in use
Measured: Through study completion, an average of 6-months
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 6-months
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
Measured: 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
Measured: Through study completion, an average of 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start15 Mar 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User-Centered DesignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FluidAI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522061
- Sponsor's protocol ID
- CLS0009
- Acronym
- Home-Stream
- Status last verified
- Feb 2025
- First submitted
- 22 Jul 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment
- ClinicalTrials.gov ID
- NCT06522061
- Acronym / sponsor ID
- Home-Stream / CLS0009
- Keywords
- Anastomotic Leak, Artificial Intelligence, Colorectal Surgery, ERAS, Stream Platform
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- FluidAI MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Stream™ PlatformStream™ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years - male or female.
- Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
- Subject underwent colorectal surgery with anastomosis.
- Subjects must be willing to comply with trial requirements.
- Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.
Key exclusion criteria (12 listed)
- Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
- 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
- The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
- Plans that the subject will be discharged in less than 3 days post-surgery.
- Subject has reported that they are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stream™ PlatformStream™ 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. | Device | Intervention Arm |
Primary outcome
Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)
Time frame: Through study completion, an average of 6-months
1. Statistical evaluation of the number of calibration errors encountered due to lay user error as reported by the healthcare providers. 2. Statistical evaluation of the number of calibration errors due to lay user errors that required intervention by the supervising healthcare provider to protect subject health and safety. 3. Occurrence of device associated adverse events including: i. Adverse Device Events (ADE) ii. Serious Adverse Device Events (SADE) iii. Unanticipated Serious Adverse Device Events (USADE) iv. Device Deficiencies
Evaluate lay users' satisfaction through user feedback survey
Time frame: Through study completion, an average of 6-months
Subject reported overall satisfaction with daily calibrations and overall device. The following parameters will be recorded on a scale of 1-5: 1. System Related Feedback * Overall feedback on Stream Platform * Overall feedback on Stream Application 2. Training Related Feedback * Overall feedback on the instructions provided by Stream Application * Overall feedback on the training material provided including but not limited to training video, infographic, etc. * Overall feedback on the in-person training conducted 3. Subject Comfort Assessment * Overall subject experience performing ADLs (Activities of Daily Living) while Stream Platform is in use. * Overall subject experience sleeping while Stream Platform is in use
3 secondary outcomes
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.
Time frame: Through study completion, an average of 6-months
Identify correlations between measurements from Stream™ Platform and current standard of care (SOC).
Time frame: Through study completion, an average of 6-months
Estimate the time taken by lay users to conduct calibration procedures
Time frame: Through study completion, an average of 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stream™ Platform in people with User-Centered Design and Anastomotic Leak, run by FluidAI Medical at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl J Brown, BSc MSc MD FRCSC (604-682-2344, cbrown@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use) (time frame: Through study completion, an average of 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.