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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832611
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : January 29, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Arteriovenous Fistula (ROX AC1) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental: Group A Anastomotic Coupler
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).
Device: Arteriovenous Fistula (ROX AC1)
The percutaneous creation of an arteriovenous fistula.

Primary Outcome Measures :
  1. Improvement in exercise capacity. [ Time Frame: 12 weeks post-procedure ]

Secondary Outcome Measures :
  1. Improvement in quality of life. [ Time Frame: 12 weeks post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832611

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Universitätsklinikum Gieβen und Marburg, Standort Marburg
Marburg, Germany, D-35043
Sponsors and Collaborators
ROX Medical, Inc.
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Principal Investigator: Claus Vogelmeier, MD Universitätsklinikum Gieβen und Marburg, Standort Marburg

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ROX Medical, Inc. Identifier: NCT00832611    
Other Study ID Numbers: ROX IX
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by ROX Medical, Inc.:
Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Chronic Emphysema
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases