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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832611
• Other study ID #: ROX IX
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: January 27, 2015
• Start date: November 2008
• Est. completion date: November 2011

Study information

• Verified date: January 2015
• Source: ROX Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.

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 information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Arteriovenous Fistula (ROX AC1)
The percutaneous creation of an arteriovenous fistula.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Gießen und Marburg, Standort Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
ROX Medical, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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