Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Boston Scientific

Status

Completed

Conditions

Emphysema

Treatments

Device: Lung Volume Reduction Coil (LVRC)

Device: Coils

Study type

Interventional

Funder types

Industry

Identifiers

NCT01220908

CLN0006

Details and patient eligibility

About

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Enrollment

36 patients

Sex

All

Ages

35 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient > 35 years of age
unilateral or bilateral emphysema
Patient has stopped smoking for a minimum of 8 weeks
Read, understood and signed the Informed Consent form

Exclusion criteria

Patient has a history of recurrent clinically significant respiratory infection
Patient has an inability to walk >140 meters
Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
Patient is pregnant or lactating
Patient has clinically significant bronchiectasis
Patient has had previous LVR surgery, lung transplant or lobectomy
Patient has been involved in other pulmonary drug studies with 30 days prior to this study
Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes