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New device aims to suck trapped air out of lungs in just 20 minutes

NCT ID NCT07665931

Symptom relief Sponsor: Azienda Socio Sanitaria Territoriale di Lodi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a single 20-minute session with a medical device called Simeox can reduce the amount of air trapped in the lungs of people with severe COPD. The device applies gentle suction during exhalation to help move air out. Researchers will measure lung function before and right after the session in 23 participants.

What this could mean

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

Active substance
Simeox electro-medical device (intermittent negative pressure device)
What this could lead to
If it works, this could point toward a non-drug, device-based way to quickly ease breathing in people with severe COPD.
What could go wrong
This is a very small, early pilot study with only 23 people and no placebo group. The effects are measured immediately after a single session, so we don't know if any benefit lasts or if it works for everyone.

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

About 23 people

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

Started

May 2026

Expected to finish

Dec 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.

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 * Diagnosis of severe or very severe COPD (GOLD stage 3-4) * Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out): * Residual volume (RV) \> 150% of predicted * Functional residual capacity (FRC) \> 130% of predicted * Total lung capacity (TLC) \> 120% of predicted * RV/TLC ratio \> 40% * Clinical stability (no exacerbations in the 3 weeks prior to enrollment) * Patients for whom assessment of the effect of Simeox® on reduction of pulmonary hyperinflation is considered clinically appropriate, in the context of exploratory device use * Written informed consent Exclusion Criteria: * Active or recent pneumothorax (\< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility * Active or recent gross haemoptysis (\< 6 weeks) or active pulmonary haemorrhage * Haemodynamic instability * Unstable cardiovascular conditions, including: * Recent myocardial infarction * Unstable angina * Uncontrolled arrhythmias * Unstable heart failure * Recent cardiothoracic surgery (\< 3 months), including oesophageal surgery * Recent thoracic trauma or severe acute lung injury * Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy * Neuromuscular diseases with respiratory muscle weakness * Inspiratory muscle weakness precluding increased respiratory effort * Oropharyngeal or oral muscle weakness * Inability to cough effectively, forcefully and autonomously * Severe restrictive lung disease (TLC \< 60% of predicted) * Airways at risk of aspiration (e.g. recent nasogastric tube feeding) * Uncontrolled gastro-oesophageal reflux disease (GERD)

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease Dyspnea

As listed by the trial registrant

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

Chronic obstructive pulmonary disease (COPD) Pulmonary hyperinflation

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

  • ASST Lodi - Presidio Ospedaliero di Codogno

    RECRUITING

    Codogno, Lombardy, 26845, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.