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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01528267
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years
* Moderate to severe airflow obstruction FEV1 \<50% Predicted
* Severe dyspnoea - mMRC ≥2
* Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
* Optimum COPD treatment for at least 6 weeks
* No COPD exacerbation for at least 6 weeks
* Less than 3 admissions for exacerbation in the preceding 12 months
Exclusion Criteria:
* Patient unable to provide informed consent
* Total lung CO uptake (TLCO) \<15% predicted and FEV1 \<15% predicted
* pO2 on air \<6.0kPa
* pCO2 on air \>8.0kPa
* Other major medical illness, e.g. lung cancer that will limit participation
* Clinically significant bronchiectasis
* Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
* Arrhythmia or cardiovascular disease that poses a risk during procedure
* Prednisolone dose greater than 10mg a day
* Prior LVRS or lobectomy
* Lung nodule requiring surgery
* Female of childbearing age with positive pregnancy test
* Subject participated in a research study of investigational drug or device in prior 30 days
* Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01528267
Study Brief:
Protocol Section:
NCT01528267