Status:
COMPLETED
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
ROX Medical, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 Obstru...
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
Exclusion
- Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD)
- Subjects with significant comorbidities
- Subjects not qualifying because of physical or psychological condition that may put them at risk of participating
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00992680
Start Date
September 1 2009
End Date
December 1 2013
Last Update
April 21 2014
Active Locations (9)
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1
Pulmonary Associates
Phoenix, Arizona, United States, 85006
2
UCLA Medical Center
Los Angeles, California, United States, 90095-1690
3
Orlando Regional Health Care System
Orlando, Florida, United States, 32803
4
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239