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A sensor in the drain line aims to catch surgical leaks sooner

NCT ID NCT05994625

Diagnosis Sponsor: FluidAI Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

After gastrointestinal surgery, a leak where the bowel was reconnected can be dangerous and costly to find. Researchers are studying the Stream Platform, a sensor placed in the drainage line that continuously measures fluid pH and conductivity for signs of a leak. The trial compares patients whose care includes the sensor with patients treated before it was introduced, tracking how quickly leaks are found, how well staff use the device, and what the care costs. It includes adults having colorectal, liver, bile duct, or trauma and acute care surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stream Platform, a sensor system that monitors drainage fluid to detect leaks after gastrointestinal surgery
What this could lead to
If it works, hospitals could catch anastomotic leaks earlier and spend less on repeat tests, longer stays, and readmissions.
What could go wrong
The study is not randomized, so differences between groups may reflect other changes in care rather than the device. The sensor may not detect leaks reliably, and it adds calibration steps that staff must follow.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 215 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anastomotic leak

Contacts and locations

Locations

  • Hamilton General Hospital - Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2, Canada

  • Juravinski Hospital- Hamilton Health Sciences

    Hamilton, Ontrario, L8V 1C3, Canada

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