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

Completed · Phase 2

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00992680

Run by

ROX Medical, Inc.

People needed

49

Starts

2009-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States
• UCLA Medical Center — Los Angeles, California, United States
• Orlando Regional Health Care System — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Veritas Clinical Specialties, LTD — Topeka, Kansas, United States
• Franklin Square Hospital — Baltimore, Maryland, United States
• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Oklahoma State University Medical Center — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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