Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

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

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-09-30

Brief Summary

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The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

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Detailed Description

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Conditions

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Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Intervention Type DEVICE

Lung Volume Reduction Coil (LVRC)

Control

Standard of Care

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Standard of Care

Interventions

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Lung Volume Reduction Coil (LVRC) (PneumRx)

Lung Volume Reduction Coil (LVRC)

Intervention Type DEVICE

Control

Standard of Care

Intervention Type DEVICE

Other Intervention Names

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LVRD LVRC Control treatment is Standard of Care

Eligibility Criteria

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Inclusion Criteria

* Patient greater than or equal to 35 years of age
* High resolution CT scan indicates unilateral or bilateral emphysema
* High resolution CT scan indicates homogeneous or heterogeneous emphysema
* Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
* Total Lung Capacity greater than 100% predicted
* Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
* Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
* Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria

* Patient has a change in FEV1 greater than 20% post-bronchodilator
* Patients DLCO less than 20% predicted
* Patient has a history of recurrent clinically significant respiratory infection
* Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
* Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
* Patient has clinically significant bronchiectasis
* Patient has giant bullae greater than 1/3 lung volume
* 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 is taking greater than 20 mg prednisone (or similar steroid) daily
* Patient is on Plavix or has not been weaned off prior to procedure
* Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No