Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246569
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2014-09-11
Brief Title:
Lung Volume Reduction Via Coils in Patients With COPD
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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-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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None