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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT01902732
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
* severe lung emphysema (FEV1\<45%, RV\>150%, TLC\>100%)
* pO2\>60 mmHg with 4l O2, pCO2 \< 60 mmHg at rest
* heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
* confirmed heterogeneity by YACTA®
* disclosure of parallel channels through relevant interlobar fissures
* age \> 30 years
* stable COPD without exacerbation 8 weeks prior to screening
* dose of cortisone\< 20 mg prednisone or equivalent OCS
* non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
* current CoHb \< 2,5%
Exclusion Criteria:
* BMI \< 18 mg/kg2
* significant bronchiectasis with sputum production of 4 tablespoons/day
* 6-minute-walk distance \< 150 m
* myocardial infarction within 6 weeks prior screening visit
* decompensated heart failure
* cardiomyopathy with moderate or severe restricted LVF
* long-term medication with Clopidogrel
* status after lung resection (Lobectomy/Pneumonectomy)
* existing pregnancy
* female subjects of child-bearing potential without acceptable forms of contraception
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01902732
Study Brief:
Protocol Section:
NCT01902732