Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Chronic Emphysema
Brief summary
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
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 in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.
Interventions
DEVICEArteriovenous Fistula (ROX AC1)
The percutaneous creation of an arteriovenous fistula.
Sponsors
ROX Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in exercise capacity. | 12 weeks post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of life. | 12 weeks post-procedure |
Countries
Germany
Outcome results
None listed