An interventional study of IAB System in Emphysema and Pulmonary Disease, Chronic Obstructive, sponsored by Pulmair Medical, Inc.. Active, not recruiting at 3 sites in 3 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Pulmair Medical, Inc. · Not applicable, Interventional, and Treatment
The Pulmair Implantable Artificial Bronchus (IAB) is a device intended for implantation into the diseased bronchi of emphysema patients. The IAB is indicated for bronchoscopic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD)/emphysema to relieve hyperinflation and allow bidirectional ventilation of the affected lobes.
The objective of this trial is to demonstrate a suitable benefit/risk profile to support a subsequent trial of the safety and effectiveness of the IAB to achieve its intended purpose.
The trial will enroll 24 subjects implanted with IAB(s), at no more than three study centers.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 245 interventional studies indexed under Emphysema.
Browse Emphysema studies →Pulmair Medical, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be treated with IAB(s)
Device: IAB System
Bronchoscopic implantation of one or multiple IABs
Safety - Incidence of respiratory serious adverse events (SAEs)
The primary endpoint is the occurrence of respiratory SAEs: * Acute asthma/bronchospasm requiring intensive/critical care unit admission * Acute COPD exacerbation (is acute onset, life-threatening, requires hospitalization) * Airway injury from IAB placement/migration/airway stenosis requiring surgical intervention * Death from procedure/IAB * Massive hemoptysis (est. \>100 ml in 24hr requiring transfusion, surgery, or arterial embolization) from procedure/IAB * Pneumonia in treated lobe requiring hospitaliz., IV antibiotics, IAB removal * Pneumonia NOT in treated lobe (is life-threatening, acute onset, requires hospitaliz. \& IV antibiotics) * Pneumothorax requiring surgery * Tension pneumothorax (is life-threatening, acute onset, requires hospitaliz. \& treatment) * Respiratory failure requiring mechanical ventilatory support \>24hr A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Safety - Incidence of other serious adverse device effects (SADEs)
All other SADEs are a secondary endpoint, made from the accumulation of adverse events (AEs) to be recorded as they occur regardless of the follow-up schedule.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), absolute change
Absolute change in Residual Volume (RV)
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Residual Volume (RV), percent change
Percent change in RV (% predicted)
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change
Absolute change in FEV1
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change
Percentage change in FEV1
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), absolute change
Absolute change in 6MWD
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Six-Minute Walk Distance (6MWD), percent change
Percent change in 6MWD
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - Modified Medical Research Council (mMRC) dyspnea score, absolute change
Absolute change in mMRC dyspnea score. Scores range from 0-4, with a decrease in score representing improved perception of disability attributable to dyspnea.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - St. George's Respiratory Questionnaire (SGRQ) total score, absolute change
Absolute change in SGRQ total score. Scores range from 0-100, with a decrease in score representing overall improvement in health, daily life, and perceived well-being.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change
Percent change in SGRQ
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - COPD Assessment Test (CAT), absolute change
Absolute changes in CAT. Scores range from 0-40, with a decrease in score representing decreased impact of cough, sputum, dyspnea, and chest tightness on overall health status.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - COPD Assessment Test (CAT) Total Score, percent change
Percent change in CAT Total Score
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, absolute change
Absolute change in EQ-5D Summary Index. Index values range from 0-1, with a decrease in index value indicating an improvement in health-related quality of life.
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Efficacy - European Quality of Life, 5-Dimensional Test (EQ-5D) Summary Index, percent change
Percent change in EQ-5D Summary Index
Time frame: From baseline to 90 days post implant (for endpoint evaluation)
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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