Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
20 participants
OBSERVATIONAL
2015-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator.
Following examination will be performed additional due to the study: determination of the strength of breathing muscles via sniff nasal pressure (PImax, PE max, P0.1), determination of the life quality index via St.-George-questionary and determination of the depression score via the Short Form 8 (SF-8) Health Survey.
After that endobronchial valve will be implanted and a permanent post-operative examination will be performed for 24 hours.
Three, respectively nine month after the implanting follow up exploration will be performed on the study patients. Once again the determination of the strength of breathing muscles, the life quality index via St.-George-questionary and the depression score via SF-8 will be performed to clarify an improvement of the physical capacity and the quality of life
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
endoscopic lung volume reduction by valves
Independent of the study, subject will get a bronchoscopy with chartis measurement in general anaesthesia. chartis measurement is a Balloon angioplasty. Balloon will be well-positioned in lung and filled by air for occlusion of lobe of the lung. System recognizes collateral ventilation of lobe of the lung via calculation of airflow resistance.
Negative result allows the endoscopic placement of selfexpandig endobronchial valves in the subject lung. Inhale airflow will be inhibit an enclosed air and liquids can exhaust.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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%)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RWTH Aachen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Dreher, Univ.-Prof.
Role: PRINCIPAL_INVESTIGATOR
RWTH University Hospital MK1
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RWTH Univerity Hospital, Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine
Aachen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-002
Identifier Type: -
Identifier Source: org_study_id