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New smart drain could spot hidden leaks after bowel surgery

NCT ID NCT06168669

Diagnosis Sponsor: Exero Medical Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This completed study tested a special surgical drain with built-in sensors that monitors for anastomotic leaks after colorectal surgery. Over 200 patients having rectal or sigmoid resections were enrolled. The drain collects data to see if it can detect leaks earlier than standard methods. Doctors were kept unaware of the device's readings to test its accuracy.

What this could mean

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

Active substance
xBar system (surgical drain with embedded sensors)
What this could lead to
If validated, this tool could help doctors spot dangerous internal leaks earlier after colorectal surgery, potentially reducing complications.
What could go wrong
This is a completed validation study, not a treatment trial. The device is only for monitoring, not preventing or treating leaks. Real-world performance may vary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

222 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

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

22 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: 1. Age ≥ 22 years 2. Indication for sigmoid or rectal resection surgery. 3. Usage of drain during the surgery (to be confirmed during the surgery) 4. Willing and able to comply with the study follow up. 5. Able and agree to provide an informed consent. Exclusion Criteria: 1. Contraindication for surgery and/or general anesthesia. 2. Pregnancy or lactation. 3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery) 4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel. 7. Participation in another interventional study during the xBar system usage.

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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 Colorectal surgery

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 328803, United States

  • AdventHealth Tampa

    Tampa, Florida, 33613, United States

  • Bryan Medical Center

    Lincoln, Nebraska, 68506, United States

  • HCA

    Houston, Texas, 77030, United States

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Kaplan MC

    Rehovot, Israel

  • Mount Sinai Health System

    New York, New York, 10029, United States

  • Northwell Health, NY

    New York, New York, 10075, United States

  • Rabin MC

    Petah Tikva, Israel

  • Soroka MC

    Beersheba, Israel

  • Stony Brook University Hospital and Cancer Center

    New York, New York, 11794-8191, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • Weill Cornell MC, NY

    New York, New York, 10021, United States

More trials for these conditions

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