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Completed

NCT Number: NCT00832611

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitätsklinikum Gieβen und Marburg, Standort Marburg

Marburg, D-35043, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arteriovenous Fistula (ROX AC1)

Device

The percutaneous creation of an arteriovenous fistula.

Primary outcomes

  1. Improvement in exercise capacity.

    Time frame: 12 weeks post-procedure

Secondary outcomes

  1. Improvement in quality of life.

    Time frame: 12 weeks post-procedure

Sponsors and collaborators

Lead sponsor

ROX Medical, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 30, 2009
Registry last updated
Jan 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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