Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT04465461
Eligibility Criteria:
Inclusion Criteria:
1. Subject is willing and able to provide informed consent and to participate in the study.
2. Subject is ≥ 40 years of age.
3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (Global Initiative for Obstructive Lung Disease (GOLD) classification).
4. Subject has a post bronchodilator 15% ≤ FEV1 ≤ 50%.
5. Subject has Total Lung Capacity (TLC) ≥ 100% predicted.
6. Subject has Residual Volume (RV) ≥ 150% predicted.
7. Subject has a normal dobutamine stress echocardiogram.
8. Subject has sufficient exercise tolerance i.e. 150m ≤ 6MWT ≤ 450m.
9. Subject has an incomplete lobar fissure i.e. \< 90%, as confirmed by CT evaluation of lung fissures.
10. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)
11. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels.
12. Subject is up to date with preventive vaccinations including seasonal influenza vaccine and pneumococcal vaccine consistent with the Victorian Department of Health and Human Services Immunization Schedule Guidelines (updated March 2018).
Exclusion Criteria:
1. Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form.
2. Subject has an acute COPD exacerbation.
3. Subject has evidence of active respiratory infection.
4. Subject has a post bronchodilator FEV1 \< 15%.
5. Subject has a Diffusing capacity for carbon monoxide (DLCO) \< 20%.
6. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the 12 months prior to study enrollment (Informed Consent Form signature page).
7. Subject has severe gas exchange abnormalities as defined by any one of the following:
1. Partial pressure of oxygen (PaO2) \< 60 mmHg
2. Partial pressure of carbon dioxide (PaCO2) \> 45 mmHg
3. Oxygen saturation (SpO2) \< 90% on ≥ 4 L/min supplemental O2 at rest
8. Subject use of systemic steroids \> 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure.
9. Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin.
10. Subject's pre-operative CT scan indicates the presence of any of the following radiological abnormalities:
1. Pulmonary nodule ≥ 0.8 cm in diameter (does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/positron emission tomography (PET)).
2. Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate.
3. Giant bullae \> 30% of the volume of either lung.
4. Significant interstitial lung disease.
5. Significant pleural disease.
11. Subject's baseline electrocardiogram (ECG) demonstrates clinically significant arrhythmias or conduction abnormalities.
12. Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis.
13. Subject has a known diagnosis of alpha-1 antitrypsin deficiency.
14. Subject is classified as having "likely" pulmonary hypertension defined as tricuspid regurgitation velocity \> 3.4m/s and/or pulmonary artery peak systolic pressure \> 45 mmHg on echocardiogram or a previous formal diagnosis of pulmonary hypertension on right heart catheterization.
15. Subject has suspected significant coronary artery disease defined as regional wall motion abnormalities on dobutamine stress echocardiogram.
16. Subject is classified as being at major cardiac risk with the presence of unstable coronary syndromes (i.e. unstable or severe angina or recent myocardial infarct), decompensated heart failure, significant arrhythmias or severe valvular disease, which warrants intensive management of the condition in accordance with current guidelines on perioperative cardiovascular risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04465461
Study Brief:
Protocol Section:
NCT04465461