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Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

This study is not yet open for participant recruitment.
Verified February 2013 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT01796392
First received: February 20, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The purpose of this research is to study a medical device that is designed to produce lung volume reduction. This device is called the PulmonX Endobronchial Valve (EBV). It has not been approved by the Food and Drug Administration (FDA) and is considered investigational. The EBV is a one-way valve that blocks off the diseased lung section to inhaled air but lets the trapped air already inside the area escape. With placement of the EBV, the diseased part of the lung collapses which allows the healthier parts of the lung to expand.

The EBV can be placed by a doctor in a diseased section of the lungs using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. With bronchoscopy, a physician can reach the airways in the lung by passing the tube through either the mouth or nose. Use of bronchoscopy for performing lung volume reduction may have fewer risks than surgery and have reduced recovery time.

This study is designed to investigate the safety and effectiveness of the Pulmonx EBV for treating emphysema symptoms as compared to a standard medical therapy program alone. It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.


Condition Intervention
Emphysema
 Device: EBV
Other: Optimal Medical Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Forced expiratory volume in 1-second (FEV1) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volumetric reduction of the treated area of the lung [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 6-minute walk distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse Events [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 183
Study Start Date: March 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBV and Optimal Medical Management
This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
 Device: EBV
This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Optimal Medical Management
This study arm will receive maximal medical management, including smoking cessation program support if necessary, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
 Other: Optimal Medical Management
This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical andd radiological evidence of emphysema
  • Currently non-smoking
  • Stable on current medication regimen
  • Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value

Exclusion Criteria:

  • Had less than two hospitalizations over the last year for a COPD exacerbation
  • Had less than two hospitalizations over the last year for pneumonia
  • Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
  • Had a heart attack or congestive heart failure within the last 6 months
  • Have heart arrhythmia
  • Is alpha-1 antitrypsin deficient
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796392

Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Principal Investigator: Gerard Criner, MD Temple University Hospital, Philadelphia, PA
Principal Investigator: Armin Ernst, MD St. Elizabeth's Hospital, Boston, MA
  More Information

No publications provided

Responsible Party: Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT01796392     History of Changes
Other Study ID Numbers: 600-0012
Study First Received: February 20, 2013
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pulmonx, Inc.:
emphysema
endobronchial valve
treatments
pulmonary rehabilitation

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013