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

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: NCT00992680
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
ROX Medical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: ROX Anastomotic Coupler System (ACS) Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : September 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Group A
Anastomotic Coupler System + standard of care per GOLD
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)

No Intervention: Group B
Standard of care per GOLD alone

Primary Outcome Measures :
  1. Improvement in exercise capacity. [ Time Frame: 3mo, 6mo, and 12mo ]

Secondary Outcome Measures :
  1. Incidence of complications and adverse events. [ Time Frame: 3mo, 6mo, and 12mo ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (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:

  • 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

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): NCT00992680

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United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095-1690
United States, Florida
Orlando Regional Health Care System
Orlando, Florida, United States, 32803
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Kansas
Veritas Clinical Specialties, LTD
Topeka, Kansas, United States, 66606
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135-2997
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Oklahoma
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
ROX Medical, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ROX Medical, Inc. Identifier: NCT00992680    
Other Study ID Numbers: US-01
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by ROX Medical, Inc.:
Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Pulmonary Emphysema
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases