Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00832611
First received: January 28, 2009
Last updated: January 27, 2015
Last verified: January 2015

January 28, 2009
January 27, 2015
November 2008
March 2011   (final data collection date for primary outcome measure)
Improvement in exercise capacity. [ Time Frame: 12 weeks post-procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832611 on ClinicalTrials.gov Archive Site
Improvement in quality of life. [ Time Frame: 12 weeks post-procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Device: Arteriovenous Fistula (ROX AC1)
The percutaneous creation of an arteriovenous fistula.
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).
Intervention: Device: Arteriovenous Fistula (ROX AC1)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
November 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00832611
ROX IX
Yes
ROX Medical, Inc.
ROX Medical, Inc.
Not Provided
Principal Investigator: Claus Vogelmeier, MD Universitätsklinikum Gieβen und Marburg, Standort Marburg
ROX Medical, Inc.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP