A multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from COPD/emphysema

Recruiting

• Conditions: COPD; emphysema; 10038716

• Registration Number: NL-OMON50551
• Lead Sponsor: Pulmair Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Signed Informed Consent
2. Diagnosis of COPD/emphysema
3. Age 40 to 75 years
4. 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/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, 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. 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:
a. Large bullae encompassing greater than 30% of either lung
b. Insufficient landmarks to evaluate the CT study using the software as it is
intended
c. 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. TLC < 100% predicted at screening
16. DLCO < 15% or > 50% of predicted value at screening
17. PaCO2 > 50 mm Hg or Denver scale greater than 55 mm Hg on room air at
screening
18. 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 arterial carboxyhemoglobin >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified