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Tiny artificial bronchus implant aims to help emphysema patients breathe

NCT ID NCT05087641

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early trial is testing a device called the Implantable Artificial Bronchus (IAB) in 20 adults with COPD or emphysema. The device is placed in the airways using a bronchoscope to relieve lung overinflation and improve airflow. The main goal is to check safety, looking for serious breathing-related complications, before moving to a larger effectiveness study.

What this could mean

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

Active substance
Implantable Artificial Bronchus (IAB) device
What this could lead to
If it works, this could point toward a new device-based treatment to help COPD/emphysema patients breathe easier by reducing lung overinflation.
What could go wrong
This is a very small, early safety trial with only 20 participants. The device involves bronchoscopic implantation and carries risks like pneumonia, airway injury, or respiratory failure. Success is far from guaranteed.

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

20 people

The number who actually took part.

Started

May 2022

Expected to finish

Jan 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

40 to 75 years

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. Signed Informed Consent 2. Diagnosis of COPD/emphysema 3. Age 40 to 75 years 4. Body Mass Index (BMI) less than 30 kg/m2 5. 6-minute walk Distance between 100 meters and 500 meters at baseline exam 6. Stable disease with less than 10 mg prednisone (or equivalent) daily 7. Non-smoking for 4 months prior to screening interview 8. FEV1 between 15% and 50% of predicted value at baseline exam 9. FEV1/Forced Vital Capacity (FVC) \< 70% 10. RV \> 175% 11. mMRC score ≥ 2 Exclusion Criteria: 1. Currently participating in another clinical study 2. Women of child-bearing potential 3. More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening 4. Any COPD exacerbations within 6 weeks of planned intervention 5. Two or more instances of pneumonia episodes in the last year at screening 6. Clinically significant mucus production or chronic bronchitis 7. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening 8. Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy 9. Clinically significant bronchiectasis 10. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days 11. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \> 45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit) 12. Suspected pulmonary nodule or lung cancer 13. High Resolution Computed Tomography (HRCT) collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows: 1. Large bullae encompassing greater than 30% of either lung 2. Insufficient landmarks to evaluate the CT study using the software as it is intended 3. All lobes are less than 25% parenchyma diseased (\< -950 HU) 14. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant 15. Total Lung Capacity (TLC) \< 100% predicted at screening 16. Diffusing Capacity of Carbon Monoxide (DLCO) \< 15% or \> 50% of predicted value at screening 17. Partial pressure of carbon dioxide (PaCO2) \> 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening 18. Partial pressure of oxygen (PaO2) \< 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening 19. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \> 2.5% at screening 20. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, CEP 90035-003, Brazil

  • Thoraxklinik, University of Heidelberg

    Heidelberg, D-69126, Germany

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

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