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

ROX Medical

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Device: ROX Anastomotic Coupler System (ACS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00992680

US-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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