COPDIAB-3NCT07086339
A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
A study testing Implantable pulmonary stent in people with COPD and Emphysema, run by Pulmair Medical, Inc. at 2 sites in 2 countries.
Trial summary
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema Read more about this study
- Who is it for?
- Ages 22 years and older
- What is being tested?
- Implantable pulmonary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- At least 22-years of age
- 18 ≤ BMI ≤ 32
- 6-minute walk Distance of between 100 - and 400 meters
- Stable disease with less than 10-mg prednisone (or equivalent) daily
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- Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).
- FEV1 between 15% and 45% of predicted value at baseline exam
- FEV1/FVC <70%
- Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.
- Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.
- RV > 175% of predicted value.
- mMRC score ≥ 2
Who cannot join
- Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
- α-1 Antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
- Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
- Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening
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- Clinically significant mucus production or chronic bronchitis
- Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening
- Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)
- Clinically significant bronchiectasis
- Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
- Suspected malignant pulmonary nodule or other lung cancer
- 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:
- Large bullae encompassing greater than 30% of either lung
- Insufficient landmarks to evaluate the CT study using the software as it is intended
- All lobes are less than 25% parenchyma diseased (< -950 HU).
- Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
- TLC < 100% predicted at screening
- DLCO < 15% or > 50% of predicted value at screening
- PaCO2 > 50 mm Hg at screening
- PaO2 < 45 mm Hg in room air at screening
- Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.
- Current diagnosis of substance abuse disorder.
- Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
DUPUYTREN University Hospital
Limoges, 87000
Clinical Research Associate, 05 55 08 73 70, elisa.dore@chu-limoges.fr
Thomas Egenod, Medical Doctor
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Study Coordinator, 050-3619194, j.hartman@umcg.nl
About this study
Official title: A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
- Being tested
- Implantable pulmonary stent
- Keywords
- IAB, Pulmair Medical, Emphysema, COPD, Lung Volume Reduction, Interventional Pulmonology, Pulmonology, COPD treatment, Emphysema treatment, lung conditions, Lung disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable pulmonary stentDevice
Implantable polymer based pulmonary stent for severe COPD/emphysema
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | One or two procedures involving placement of up to 10 IAB implants in one or both lungs Receives: Device: Implantable pulmonary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
The incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint.
Measured: Ninety (90) days from the last IAB implanted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start4 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmair Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086339
- Sponsor's protocol ID
- IAB3-CIP
- Acronym
- IAB-3
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema
- ClinicalTrials.gov ID
- NCT07086339
- Acronym / sponsor ID
- IAB-3 / IAB3-CIP
- Keywords
- IAB, Pulmair Medical, Emphysema, COPD, Lung Volume Reduction, Interventional Pulmonology, Pulmonology, COPD treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pulmair Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Implantable pulmonary stentOne or two procedures involving placement of up to 10 IAB implants in one or both lungs |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- At least 22-years of age
- 18 ≤ BMI ≤ 32
- 6-minute walk Distance of between 100 - and 400 meters
Key exclusion criteria (26 listed)
- Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment
- α-1 Antitrypsin deficiency
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening
- Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable pulmonary stentImplantable polymer based pulmonary stent for severe COPD/emphysema | Device | Treatment group |
Primary outcome
Incidence of serious adverse events
Time frame: Ninety (90) days from the last IAB implanted.
The incidence of respiratory serious adverse events related to the device or procedure (SADEs) through the 90-day endpoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable pulmonary stent in people with COPD and Emphysema, run by Pulmair Medical, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VP Clinical Operations (+1-858-369-0000, tkruger@pulmair.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: Ninety (90) days from the last IAB implanted.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.