A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: ROX Anastomotic Coupler System (ACS)
- Registration Number
- NCT00992680
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A ROX Anastomotic Coupler System (ACS) Anastomotic Coupler System + standard of care per GOLD
- Primary Outcome Measures
Name Time Method Improvement in exercise capacity. 3mo, 6mo, and 12mo
- Secondary Outcome Measures
Name Time Method Incidence of complications and adverse events. 3mo, 6mo, and 12mo
Trial Locations
- Locations (9)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Orlando Regional Health Care System
🇺🇸Orlando, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Franklin Square Hospital
🇺🇸Baltimore, Maryland, United States
Veritas Clinical Specialties, LTD
🇺🇸Topeka, Kansas, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Oklahoma State University Medical Center
🇺🇸Tulsa, Oklahoma, United States