Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145548
Status:
COMPLETED
Last Update Posted:
2011-06-16
First Post:
2005-09-01
Brief Title:
Pilot Study of the Spiration IBV System
Sponsor:
Olympus Corporation of the Americas
Organization:
Olympus Corporation of the Americas
Study Overview
Official Title:
Pilot Study of the Spiration IBV System
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
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:
The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema using standard bronchoscopy The valve is designed to limit airflow to a selected portion of the lung producing a reduction in lung volume which may improve pulmonary function in patients with emphysema
Detailed Description:
This pilot study is an open enrollment prospective study with each subject serving as their own control The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study This proposal shall be evaluated at the conclusion of the pilot study
PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study In this initial pilot study eligible subjects will have severe heterogeneous predominantly upper lobe emphysema as defined by the American Thoracic Society ATS 1 and the NETT Research Group2
These subjects also will be patients who have been screened as potential candidates for LVRS but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS2 Patients also will be able to tolerate a flexible bronchoscopy procedure
Patients who have been screened and accepted for a lung transplant procedure or LVRS and are currently registered or scheduled for such a procedure are not eligible for enrollment in this pilot study
Patients with an FEV1 20 predicted and either homogeneous emphysema or DLCO 20 will be excluded from enrollment in this pilot study3
Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System Up to 15 clinical centers will be selected to enroll and treat subjects
PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study In this initial pilot study eligible subjects will have severe heterogeneous predominantly upper lobe emphysema as defined by the American Thoracic Society ATS 1 and the NETT Research Group2
These subjects also will be patients who have been screened as potential candidates for LVRS but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS2 Patients also will be able to tolerate a flexible bronchoscopy procedure
Patients who have been screened and accepted for a lung transplant procedure or LVRS and are currently registered or scheduled for such a procedure are not eligible for enrollment in this pilot study
Patients with an FEV1 20 predicted and either homogeneous emphysema or DLCO 20 will be excluded from enrollment in this pilot study3
Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System Up to 15 clinical centers will be selected to enroll and treat subjects
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