Anastomotic LeakPhase 3CostALNCT05994625

Economic Evaluation of Stream™ Platform

A Phase 3 study testing Stream™ Platform and Stream™ Platform with Risk Score Omitted in people with Anastomotic Leak, run by FluidAI Medical at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anastomotic Leak
What is being tested?: Stream™ Platform and Stream™ Platform with Risk Score Omitted
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: 2 sitesCanada
Study dates: 6 Dec 2023to Dec 2027
Phase: Phase 3
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 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Hamilton General Hospital - Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Juravinski Hospital- Hamilton Health Sciences
Hamilton, Ontrario, L8V 1C3

Other trials in Canada

About this study

Official 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.

Conditions: Anastomotic Leak
Being tested: Stream™ Platform, Stream™ Platform with Risk Score Omitted
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 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.
Stream™ Platform with Risk Score OmittedDevice
Also called NERv's Inline Device
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.

Study groups in NCT05994625
Study group	Role	What they receive
Intervention Group	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. 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. Receives: Device: Stream™ Platform
Control Group	Sham comparator	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. Receives: Device: Stream™ Platform with Risk Score Omitted

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Does Stream™ Platform integrate well with the existing clinical workflow (3)?
Quantify the overall reported satisfaction score of the CRC/delegate through surveys.
Measured: Through study completion, an average of 1 year
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.
Measured: 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)?
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.
Measured: Upon study completion (12 months)
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.
Measured: Upon study completion (12 months)

Secondary outcomes (5)

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).
Measured: 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)?
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.
Measured: Upon study completion (12 months)
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)?
1. 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.
Measured: Upon study completion (12 months)
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.
Measured: Upon study completion (12 months)
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.
Measured: Upon study completion (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 2023Dec 2027

First posted16 Aug 2023
Study start6 Dec 2023
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anastomotic LeakStudies 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 3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 215 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05994625
Sponsor's protocol ID: CLS0007
Acronym: CostAL
Status last verified: Sep 2026
First submitted: 18 Jul 2023
Last updated: 11 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
Not yet recruiting
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
Anastomotic Leaks
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage

All Anastomotic Leak trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery
ClinicalTrials.gov ID: NCT05994625
Acronym / sponsor ID: CostAL / CLS0007
Conditions: Anastomotic Leak
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 215 participants (estimated)
Lead sponsor: FluidAI MedicalIndustry (pharma, biotech, devices)
Collaborators: Hamilton Health Sciences Corporation, Ontario Bioscience Innovation Organization
Study start: 6 Dec 2023 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 16 Aug 2023 (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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Group	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. 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.
Control Group	Sham comparator	Device: Stream™ Platform with Risk Score OmittedStream™ 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

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 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.	Device	Intervention Group
Stream™ Platform with Risk Score OmittedAlso: NERv's Inline DeviceStream™ 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.	Device	Control Group

Primary outcome

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
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
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.
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.
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.
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.

5 secondary outcomes

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)
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)
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)
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)
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)

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 11 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Anastomotic Leak

Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
Not yet recruiting
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
Anastomotic Leaks
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stream™ Platform and Stream™ Platform with Risk Score Omitted in people with Anastomotic Leak, run by FluidAI Medical at 2 sites 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Does Stream™ Platform integrate well with the existing clinical workflow (1)? (time frame: Through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994625.

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 11 Sep 2026.