Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

Boston Scientific

Status and phase: Completed; Phase 2; Phase 1

Conditions: Emphysema

Treatments: Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328899

CLN0011

Details and patient eligibility

About

This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

Enrollment: 60 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 35 years of age
• bilateral heterogenous 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 significant respirator 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 clinical significant bronchiectasis
• Patient has had previous LVR surgery, lung transplant or lobectomy
• Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Lung Volume Reduction Coil (LVRC)

Experimental group

Description:

Lung Volume Reduction Coil (LVRC)

Treatment:

Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)