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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT03264768
Eligibility Criteria:
Inclusion Criteria:
* Age 40 - 75 years
* Confluent or destructive heterogeneous emphysema on CT
* Smoking cessation for at least 6m (proven by urinary cotinine levels)
* FEV1 \< 60 %predicted, RV \> 150 %predicted, TLC \> 90 %predicted
* RV/TLC ratio ≥ 0.55
* 6MWD \< 450 meter
* mMRC ≥ 2
* Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
* LABA-LAMA bronchodilator therapy as a minimum therapy
* Able to sign informed consent
Exclusion Criteria:
* Homogenous emphysema
* PaCO2 \> 60 mmHg with ambient air
* PaO2 \< 45 mmHg with ambient air
* Previous LVRS, lung transplantation, lobectomy
* TLCO or FEV1 \< 20% predicted
* Significant pulmonary hypertension (PaPsyst \> 50 mm Hg)
* Heart failure with reduced EF (\< 40%)
* 6MWD \< 100 meter
* BODE index ≥ 7 and eligible for transplantation
* Active cancer
* Life expectancy \< 3 months
* Significant lung disease other than COPD/emphysema
* Unable to comply with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03264768
Study Brief:
Protocol Section:
NCT03264768