Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase 4
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Arteriovenous Fistula (ROX AC1)
- Registration Number
- NCT00832611
- Lead Sponsor
- ROX Medical, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: Group A Anastomotic Coupler Arteriovenous Fistula (ROX AC1) Device: ROX Anastomotic Coupler System (ACS). The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
- Primary Outcome Measures
Name Time Method Improvement in exercise capacity. 12 weeks post-procedure
- Secondary Outcome Measures
Name Time Method Improvement in quality of life. 12 weeks post-procedure
Trial Locations
- Locations (1)
Universitätsklinikum Gieβen und Marburg, Standort Marburg
🇩🇪Marburg, Germany