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

Sponsor:	ROX Medical, Inc.
Information provided by (Responsible Party):	ROX Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00992680

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Device: ROX Anastomotic Coupler System (ACS)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

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

Primary Outcome Measures:

Improvement in exercise capacity. [ Time Frame: 3mo, 6mo, and 12mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of complications and adverse events. [ Time Frame: 3mo, 6mo, and 12mo ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992680

Locations

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.

More Information

Publications:

Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81.

Responsible Party:	ROX Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00992680 History of Changes
Other Study ID Numbers:	US-01
Study First Received:	October 7, 2009
Last Updated:	May 22, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ROX Medical, Inc.:

Lung Disease
Chronic Airflow Obstruction
Chronic Bronchitis
Pulmonary Emphysema
Walk

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012