Emphysema or COPDIAB-2NCT07119229
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
A study testing Implantable Artificial Bronchus in people with Emphysema or COPD and Emphysema, run by Pulmair Medical, Inc. at 4 sites in United States.
Trial summary
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Emphysema or COPD, Emphysema, COPD
- What is being tested?
- Implantable Artificial Bronchus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Mar 2026to Nov 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 between 100-meters and 400-meters at baseline exam.
- Stable disease with less than 10-mg prednisone (or equivalent) daily
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- Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).
- FEV1 between 15% and 50% of predicted value at baseline exam.
- FEV1/FVC <70%.
- Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation <-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 (< -950HU) as determined by CT core lab.
- RV > 175% of predicted value.
- mMRC score ≥ 2.
Who cannot join
- 1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
- 2. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.
- 5. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
- 6. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
- 7. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
- 9. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).
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- 10. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.
- 12. 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). Note: the echocardiogram is not a required screening procedure.
- 13. Suspected malignant pulmonary nodule or other lung cancer. 14. 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) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.
- 16. TLC < 100% predicted at screening. 17. DLCO < 15% or > 50% of predicted value at screening. 18. PaCO2 > 50 mm Hg at screening. 19. PaO2 < 45 mm Hg in room air at screening. 20. Plasma cotinine level > 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) >2.5% at screening.
- 21. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.
- 23. 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Clinical Research Coordinator, 617-632-8252, BIDMC-IPResearchTeam@bidmc.harvard.edu
Adnan Majid, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Adriana Martinez, 312-926-6680, adriana.martinez@northwestern.edu
Momen M Wahidi, MD, MBA
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Matthew Stanford, MSc, (414) 955-7030, mstanford@mcw.edu
Dominique Hill, (414) 955-7494, dohill@mcw.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Alberto Toledo, 415-767-9143, alberto.toledo@ucsf.edu
Eric Seeley, MD
About this study
Official title: A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
Read the detailed description
IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.
- Conditions
- Emphysema or COPD, Emphysema, COPD
- Being tested
- Implantable Artificial Bronchus
- Keywords
- IAB, Stent, Emphysema treatment, emphysema study, COPD treatment, COPD study, EBV alternative, Lung volume reduction, Lung hyperinflation treatment
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Artificial BronchusDevice
Also called IAB
The Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.
| Study group | Role | What they receive |
|---|---|---|
| All subjects will receive study treatment | Experimental | All subjects will receive treatment with a maximum of 10 Implantable Artificial Bronchus (IABs) which are polymer based stents that can be permanently placed in any diseased lobe of the lungs. Receives: Device: Implantable Artificial Bronchus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in residual volume (RV)
The primary endpoint is the absolute change in residual volume (RV) from baseline to endpoint as recorded 90-days after the last implant.
Measured: 90 days after last IAB is implanted
Secondary outcomes (1)
Changes from baseline to 90-days, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence as well as all related adverse device effects
Absolute change in Forced Expiratory Volume in one second (FEV1) from baseline to endpoint; Absolute change in residual volume/total lung capacity (RV/TLC) from baseline to endpoint; Absolute change in Six-minute Walk Distance (6MWD); Absolute change in the St George's Respiratory Questionnaire (SGRQ) total score where a higher score represents more significant impact of the disease on wellbeing; Absolute change in the Modified Medical Research Counsel Questionnaire (mMRC) dyspnea score; Absolute changes in COPD Assessment Test (CAT), with higher scores indicating a greater impact of COPD on health; Absolute change in EQ-5D Summary Index Questionnaire which measures self-reported assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression with a higher score indicating more significant impact of the disease on each dimension.
Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs) and Device Deficiencies (DDs) with SADE potential
Measured: 90 days after last implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start25 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmair Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Majid, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119229
- Sponsor's protocol ID
- IAB2-CIP
- Acronym
- IAB-2
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema
- ClinicalTrials.gov ID
- NCT07119229
- Acronym / sponsor ID
- IAB-2 / IAB2-CIP
- Conditions
- Emphysema or COPD, Emphysema, COPD
- Keywords
- IAB, Stent, Emphysema treatment, emphysema study, COPD treatment, COPD study, EBV alternative, Lung volume reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pulmair Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Aug 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 taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
Detailed description
IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects will receive study treatment | Experimental | Device: Implantable Artificial BronchusAll subjects will receive treatment with a maximum of 10 Implantable Artificial Bronchus (IABs) which are polymer based stents that can be permanently placed in any diseased lobe of the 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 between 100-meters and 400-meters at baseline exam.
Key exclusion criteria (15 listed)
- 1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..
- 2. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.
- 5. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.
- 6. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.
- 7. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6-months of screening.
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 Artificial BronchusAlso: IABThe Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema. | Device | All subjects will receive study treatment |
Primary outcome
Absolute change in residual volume (RV)
Time frame: 90 days after last IAB is implanted
The primary endpoint is the absolute change in residual volume (RV) from baseline to endpoint as recorded 90-days after the last implant.
1 secondary outcome
Changes from baseline to 90-days, involving pulmonary function, exercise tolerance, dyspnea burden and occurrence as well as all related adverse device effects
Time frame: 90 days after last implant
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 14 Oct 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.
Adnan Majid, MD principal investigator
Beth Israel Deaconess Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Artificial Bronchus in people with Emphysema or COPD and Emphysema, run by Pulmair Medical, Inc. at 4 sites in United States.
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 15 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 Clincal Operations (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?
Absolute change in residual volume (RV) (time frame: 90 days after last IAB is 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 14 Oct 2026.