Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00832611
First received: January 28, 2009
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ROX Medical, Inc.:

Primary Outcome Measures:
  • Improvement in exercise capacity. [ Time Frame: 12 weeks post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life. [ Time Frame: 12 weeks post-procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Arteriovenous Fistula (ROX AC1)
    The percutaneous creation of an arteriovenous fistula.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832611

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

Publications:
Cooper CB, Celli B. Venous Admixture in COPD: Pathophysiology and Therapeutic Approaches. COPD: Journal of Chronic Obstructive Pulmonary Disease 5(6): 376-381, 2008.

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT00832611     History of Changes
Other Study ID Numbers: ROX IX
Study First Received: January 28, 2009
Last Updated: May 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ROX Medical, Inc.:
Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Chronic Emphysema

Additional relevant MeSH terms:
Arteriovenous Fistula
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013