Lung Volume Reduction Via Coils in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT02246569|
Recruitment Status : Unknown
Verified November 2015 by RWTH Aachen University.
Recruitment status was: Recruiting
First Posted : September 22, 2014
Last Update Posted : November 20, 2015
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 the coils distended lung sections shrink so that healthy parts can expand.
In the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.
|Condition or disease|
|Chronic Obstructive Pulmonary Disease (COPD)|
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-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.
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. After reading the patient information patient may submit his informed written consent. After that information on the risks will be given by a treating physician.
Following examination will be performed additional due to the study: determination of the strength of breathing muscles, determination of the life quality index via St.-George-questionary and determination of the depression score via SF-8-questionary (short form-8).
After that coils 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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
- breathing strength [ Time Frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy ]Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246569
|Contact: Michael Dreher, Univ.-Prof.||+49241 80 email@example.com|
|Contact: Tobias Müller, PD Dr.med.||+49241 80 firstname.lastname@example.org|
|RWTH Univerity Hospital MK1||Recruiting|
|Aachen, Germany, 52074|
|Contact: Michael Dreher, Univ.-Prof. +492418088763 email@example.com|
|Contact: Tobias Müller, PD Dr.med. +492418088763 firstname.lastname@example.org|
|Principal Investigator:||Michael Dreher, Univ.-Prof.||RWTH University Hospital MK1|