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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05854550
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 35 and ≤ 80 years old
2. Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
3. At least one target lobe with \> 35% destruction (percent of voxels with \< -950 Hounsfield units on CT)
4. Post-bronchodilator ratio of FEV1/FVC \< 0.7 at screening
5. Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening
6. Post-bronchodilator RV \> 180% predicted
7. Post-bronchodilator RV/TLC ≥ 0.55 at screening
8. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4
9. Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation
10. Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study
11. Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance)
12. Cognitively and physically able to provide written informed consent and complete participant questionnaires
Exclusion Criteria:
1. Arterial blood PaCO2 \> 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
2. DLCO \<20% at screening
3. Steroid therapy of 10 mg prednisolone (prednisone) or more per day
4. Three or more acute exacerbations of COPD in the past year before enrollment
5. Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
6. Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
7. Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
8. Known history of pulmonary arterial hypertension
9. Presence of a giant bulla (≥ 30% of hemithorax)
10. History of excessive dynamic airway collapse of the trachea or main bronchi
11. History of adult asthma or chronic bronchitis
12. Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
13. Unequivocal and symptomatic bronchiectasis
14. Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
15. Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic \> 200 mmHg or diastolic \> 110 mmHg at screening or prior to first Apreo Procedure
16. Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding
17. On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure
18. Coronary artery disease with angina
19. History of myocardial infarction within 6 months
20. History of a stroke less than 1 year before the first Apreo Procedure
21. Clinical history of heart failure with documented LVEF ≤ 40%
22. Clinical history of diabetes with a HbA1c \> 9.0%
23. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease)
24. Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device
25. Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration
26. Known hypersensitivity to nitinol
27. Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
28. Any disease or condition likely to limit survival to less than one year
29. Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure
30. Currently enrolled in another trial and actively receiving experimental treatment
31. Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT05854550
Study Brief:
Protocol Section:
NCT05854550