Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Verified date | April 2014 |
Source | ROX Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 2013 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Franklin Square Hospital | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Caritas St. Elizabeth's Medical Center | Boston | Massachusetts |
United States | UCLA Medical Center | Los Angeles | California |
United States | Orlando Regional Health Care System | Orlando | Florida |
United States | Pulmonary Associates | Phoenix | Arizona |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | Veritas Clinical Specialties, LTD | Topeka | Kansas |
United States | Oklahoma State University Medical Center | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
ROX Medical, Inc. |
United States,
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in exercise capacity. | 3mo, 6mo, and 12mo | No | |
Secondary | Incidence of complications and adverse events. | 3mo, 6mo, and 12mo | Yes |
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