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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Emphysema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lung Volume Reduction Coil (LVRC)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Lung Volume Reduction Coil

Interventions

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

Lung Volume Reduction Coil

Intervention Type DEVICE

Other Intervention Names

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Lung Volume Reduction Device (LVRD)

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No