NCT05087641Active, not recruiting
A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 28 Sept 2021
- Start date
- 3 May 2022
- Primary completion date
- 27 Mar 2024
- Lead sponsor
- Pulmair Medical, Inc.
- Diseases
- COPD
- NCT number
- NCT05087641
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 3 May 2022 to the primary completion date, 27 Mar 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
- 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)
Other illness
- Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
- Suspected pulmonary nodule or lung cancer
- Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
- 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
Lab values
- Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days
Other
- Currently participating in another clinical study
- Women of child-bearing potential
- More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening
- Any COPD exacerbations within 6 weeks of planned intervention
- Two or more instances of pneumonia episodes in the last year at screening
- Clinically significant mucus production or chronic bronchitis
- Clinically significant bronchiectasis
- 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:
- 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)
- Total Lung Capacity (TLC) \< 100% predicted at screening
- Diffusing Capacity of Carbon Monoxide (DLCO) \< 15% or \> 50% of predicted value at screening
- Partial pressure of carbon dioxide (PaCO2) \> 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening
- Partial pressure of oxygen (PaO2) \< 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening
- Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \> 2.5% at screening
Who the study is looking for
- Signed Informed Consent
- Diagnosis of COPD/emphysema
- Age 40 to 75 years
- Body Mass Index (BMI) less than 30 kg/m2
- 6-minute walk Distance between 100 meters and 500 meters at baseline exam
- Stable disease with less than 10 mg prednisone (or equivalent) daily
- Non-smoking for 4 months prior to screening interview
- FEV1 between 15% and 50% of predicted value at baseline exam
- FEV1/Forced Vital Capacity (FVC) \< 70%
- RV \> 175%
- mMRC score ≥ 2
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Thoraxklinik, University of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.