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.
Who can participate
Age range40 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
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
What they're measuring
1
Safety - Incidence of respiratory serious adverse events (SAEs)
Timeframe: From baseline to 90 days post implant (for endpoint evaluation)