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Tiny study tests if belly binder harms lung function

NCT ID NCT07154589

Knowledge-focused Sponsor: Unity Health Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at how the AbClo device, a non-invasive abdominal binder used to keep the abdomen closed after surgery, affects lung function in 18 intensive care patients on ventilators. Researchers will measure lung pressure and volume before and after adjusting the device to the manufacturer's recommended setting, and again after the abdomen is surgically closed. The goal is to see if the device causes harmful changes to breathing and if adjusting the ventilator can help.

What this could mean

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

Active substance
AbClo fascial approximation device
What this could lead to
If successful, this could help doctors adjust the AbClo device to minimize negative effects on lung function in open abdomen patients.
What could go wrong
This is a very small, early study (18 people) that only measures short-term changes. It may not lead to any change in patient care or outcomes.

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.

Participants

About 18 people

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

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation

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: * Adult patients aged 18 years or older * Patients admitted to an ICU * Patients with postoperative abdominal surgery with open abdomen * Patients treated with AbClo device * Patients intubated and mechanically ventilated * Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3 Exclusion Criteria: * Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use * Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109/L, or the latest INR higher than 2.0 * Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion * Patients with bronchopleural fistula * Patients with measured and uncontrolled increased intracranial pressure

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As listed by the trial registrant

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

Mechanical ventilation Open abdomen

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B1W8, Canada

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