Status:
UNKNOWN
Lung Volume Reduction Via Coils in Patients With COPD
Lead Sponsor:
RWTH Aachen University
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18+ years
Brief Summary
For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of t...
Detailed Description
In line with routine explorations it is necessary to clarify whether a patient is suitable for the endoscopic lung volume reduction. To address this question lung function diagnostics, 6-minutes-walk-...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
October 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02246569
Start Date
October 1 2015
End Date
September 1 2016
Last Update
November 20 2015
Active Locations (1)
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1
RWTH Univerity Hospital MK1
Aachen, Germany, 52074