Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02879331
Status:
UNKNOWN
Last Update Posted:
2019-03-01
First Post:
2016-07-29
Brief Title:
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Overview
Official Title:
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
Status:
UNKNOWN
Status Verified Date:
2019-02
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:
CYCLONE
Brief Summary:
The study hypothesis is that patients with homogeneous emphysema behave differently compared to heterogeneous emphysema with respect to exercise capacity A better understanding of this difference will allow the investigators to choose the best treatment for each type of patient
The main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils eLVR
As a secondary purpose the investigators want to perform an exploratory randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema
The main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils eLVR
As a secondary purpose the investigators want to perform an exploratory randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema
Detailed Description:
The study plans to include patients with severe emphysema candidates to go through eLVR with coils that fulfill all inclusion criteria and none of the exclusion criteria Patients with both homogeneous and heterogeneous emphysema will be included
The main study intervention is the performance of a cyclo ergometry not included in daily clinical practice before basal and 6 months after going through the eLVR with coils
The subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches
Group A treatment with 10 coils in upper lobes
Group B treatment with 15 coils spared in upper and lower lobes
Thus the study includes
for all patients the performance of two cycloergometries before and 6 months after the eLVR
Also for the subset of homogeneous emphysema patients an open label randomized parallel two arm exploratory clinical trial
Sample size has not been formally calculated as there are no previous available data for the primary endpoint change inspiratory capacity Thus 35 patients will be included according to the expected number of patients Recruitment period will be 24 months and patient follow up will be 6 months
The main study intervention is the performance of a cyclo ergometry not included in daily clinical practice before basal and 6 months after going through the eLVR with coils
The subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches
Group A treatment with 10 coils in upper lobes
Group B treatment with 15 coils spared in upper and lower lobes
Thus the study includes
for all patients the performance of two cycloergometries before and 6 months after the eLVR
Also for the subset of homogeneous emphysema patients an open label randomized parallel two arm exploratory clinical trial
Sample size has not been formally calculated as there are no previous available data for the primary endpoint change inspiratory capacity Thus 35 patients will be included according to the expected number of patients Recruitment period will be 24 months and patient follow up will be 6 months
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