Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992680
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2009-10-07
Brief Title:
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
ROX Medical Inc
Organization:
ROX Medical Inc
Study Overview
Official Title:
A Prospective Randomized Multicenter Open Label Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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 purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System ACS with standard of care as defined per GOLD in patients with Chronic Obstructive Pulmonary Disease COPD as compared to standard of care alone
Detailed Description:
Chronic Obstructive Pulmonary Disease COPD is a chronic disease that leads to irreversible changes in the lung structure but also to systemic changes in the body that can influence the severity of the disease The irreversible changes to the lungs can be seen in limitations to the pulmonary function The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System
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