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Smart drain sensor could spot dangerous leaks after abdominal surgery

NCT ID NCT04582708

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tested a device that attaches to surgical drains to continuously measure the pH and electrical conductivity of fluid from the abdomen. The goal was to see if changes in these readings could signal a leak or fistula earlier than standard methods. The study enrolled 316 adults who had abdominal surgery and a drain in place. The device is not yet proven to work in routine care, but the data will help build a model for future detection.

What this could mean

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

Active substance
NERv's Inline Device (a sensor that attaches to surgical drains to measure pH and conductivity of fluid)
What this could lead to
If successful, this device could help doctors spot internal leaks or fistulas earlier after surgery, potentially reducing serious complications.
What could go wrong
This is a small, single-arm feasibility study, not a randomized trial. The device is still experimental and may not reliably detect complications in all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

316 people

The number who actually took part.

Started

Nov 2020

Finished

Sep 2024

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 Informed Consent Form (ICF) * Subjects must be willing to comply with trial requirements * Subject has a peritoneal drain, such as Jackson Pratt drain attached post abdominal surgery Exclusion Criteria: * Plans that the subject will be discharged in less than 8 hours post-surgery * Involvement in the planning and conduct of the clinical investigation * Subject is participating in another investigational drug or device study which may interfere with the endpoints of this study * NERv's Inline Device does not attach to drain used on the subject

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak Fistula

As listed by the trial registrant

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

Anastomotic leak Fistula POPF Postoperative leak Postoperative pancreatic fistula

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Grand River Hospital

    Kitchener, Ontario, N2G 1G3, Canada

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2, Canada

  • Juravinski Hospital- Hamilton Health Sciences

    Hamilton, Ontrario, L8V 1C3, Canada

  • King Saud University Medical City

    Riyadh, Saudi Arabia

  • St. Joseph's Health Centre

    Toronto, Ontario, M6R 1B5, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

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