Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
Status | Completed |
Enrollment | 46 |
Est. completion date | November 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination. Exclusion Criteria: - Subject not qualifying because of physical or psychological condition that may put them at risk of participating. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Gießen und Marburg, Standort Marburg | Marburg |
Lead Sponsor | Collaborator |
---|---|
ROX Medical, Inc. |
Germany,
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in exercise capacity. | 12 weeks post-procedure | No | |
Secondary | Improvement in quality of life. | 12 weeks post-procedure | No |
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