A Multicenter, Prospective Trial of the IAB in Adults Suffering From COPD/Emphysema

N/AActive Not RecruitingNCT05087641

Pulmair Medical, Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Emphysema Pulmonary Disease, Chronic Obstructive

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed Informed Consent 2. Diagnosis of COPD/emphysema 3. Age 40 to 75 years 4. Body Mass Index (BMI) less than 30 kg/m2 5. 6-minute walk Distance between 100 meters and 500 meters at baseline exam 6. Stable disease with less than 10 mg prednisone (or equivalent) daily 7. Non-smoking for 4 months prior to screening interview 8. FEV1 between 15% and 50% of predicted value at baseline exam 9. FEV1/Forced Vital Capacity (FVC) \< 70% 10. RV \> 175% 11. mMRC score ≥ 2 Exclusion Criteria: 1. Currently participating in another clinical study 2. Women of child-bearing potential 3. More than 2 COPD exacerbation episodes requiring hospitalization in the last year at screening 4. Any COPD exacerbations within 6 weeks of planned intervention 5. Two or more instances of pneumonia episodes in the last year at screening 6. Clinically significant mucus production or chronic bronchitis 7. Myocardial Infarction or unstable / uncontrolled congestive heart failure within 6 months of screening 8. Prior lung transplant, Lung Volume Reduction Surgery (LVRS), bullectomy or lobectomy 9. Clinically significant bronchiectasis 10. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days 11. 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) 12. Suspected pulmonary nodule or lung cancer 13. 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: 1. Large bullae encompassing greater than 30% of either lung 2. Insufficient landmarks to evaluate the CT study using the software as it is intended 3. All lobes are less than 25% parenchyma diseased (\< -950 HU) 14. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant 15. Total Lung Capacity (TLC) \< 100% predicted at screening 16. Diffusing Capacity of Carbon Monoxide (DLCO) \< 15% or \> 50% of predicted value at screening 17. Partial pressure of carbon dioxide (PaCO2) \> 50 mm Hg or Denver scale greater than 55 mm Hg on room air at screening 18. Partial pressure of oxygen (PaO2) \< 45 mm Hg or Denver scale less than 30 mm Hg on room air at screening 19. Plasma cotinine level \> 13.7 ng/ml or carboxyhemoglobin (arterial or ear lobe capillary) \> 2.5% at screening 20. 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

Locations (3)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Thoraxklinik, University of Heidelberg

Heidelberg, Germany

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

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.