NCT00832611

Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: ROX Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Arteriovenous Fistula (ROX AC1)	The percutaneous creation of an arteriovenous fistula.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-03-01
• Completion: 2011-11-01
• First posted: 2009-01-30
• Last updated: 2015-01-29

Locations

1 site across 1 country: Germany