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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IAB System | Experimental | Patients will be treated with IAB(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IAB System | Device | Bronchoscopic implantation of one or multiple IABs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence of respiratory serious adverse events (SAEs) | The primary endpoint is the occurrence of respiratory SAEs:
A thoracic SAE composite, based on number of subjects experiencing a thoracic SAE, will also be calculated and tabulated. | From baseline to 90 days post implant (for endpoint evaluation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Residual Volume (RV), absolute change |
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Inclusion Criteria:
Exclusion Criteria:
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
Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening
Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy
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 (completed within the last 3 months prior to screening visit)
Suspected pulmonary nodule or lung cancer
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:
Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant
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
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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| Name | Affiliation | Role |
|---|---|---|
| Hugo Goulart de Oliveira, MD, PhD | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Porto Alegre | CEP 90035-003 | Brazil | |||
| Thoraxklinik, University of Heidelberg |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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This is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema. There is no control group or comparator.
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Absolute change in Residual Volume (RV) |
| From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Residual Volume (RV), percent change | Percent change in RV (% predicted) | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Forced Expiratory Volume in one second (FEV1), absolute change | Absolute change in FEV1 | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Forced Expiratory Volume in one second (FEV1), percentage change | Percentage change in FEV1 | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Six-Minute Walk Distance (6MWD), absolute change | Absolute change in 6MWD | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - Six-Minute Walk Distance (6MWD), percent change | Percent change in 6MWD | 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. | 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. | From baseline to 90 days post implant (for endpoint evaluation) |
| Efficacy - St. George's Respiratory Questionnaire (SGRQ), percent change | Percent change in SGRQ | 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. | 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 | 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. | 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 | From baseline to 90 days post implant (for endpoint evaluation) |
| Heidelberg |
| D-69126 |
| Germany |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |