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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT02246569
Eligibility Criteria:
Inclusion Criteria:
* bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians
* homogeneous or heterogeneous emphysema
* previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
* nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) \< 2%
* FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
* total lung capacity (TLC) ≥ 100% of reference value
* residual volume (RV) ≥ 175% of reference value
* patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
* signed Informed Consent
* understanding of the nature, significance and implications of the study
* ability to understand and follow instructions of the study stuff
Exclusion Criteria:
* echo-cardiographic right ventricular pressure (PAPsys) \> 50 mmHg
* indication for a permanent anticoagulation therapy (besides ASS)
* pulmonal cachexia
* pregnancy and lactating
* permanent treatment with \> 20 mg Prednison per day
* hospitalisation due to a COPD-exacerbation in the last 3 months
* \> 3 steroid-treated exacerbations in the last year
* Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
* severe diffusion impairment (DLCO \< 20%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02246569
Study Brief:
Protocol Section:
NCT02246569