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NCT Number: NCT00992680

A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.

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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 Pulmonary Emphysema Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pulmonary Associates, Phoenix, Arizona, United States

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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 to the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System.

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

  • Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD)
  • Subjects with significant comorbidities
  • Subjects not qualifying because of physical or psychological condition that may put them at risk of participating

Treatment and study plan

ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

Device

The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)

Primary outcomes

  1. Improvement in exercise capacity.

    Time frame: 3mo, 6mo, and 12mo

Secondary outcomes

  1. Incidence of complications and adverse events.

    Time frame: 3mo, 6mo, and 12mo

Sponsors and collaborators

Lead sponsor

ROX Medical, Inc.

Industry

Registry information

Official study title

A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Oct 9, 2009
Registry last updated
Apr 21, 2014

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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