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

This study is currently recruiting participants.
Verified December 2013 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT01796392
First received: February 20, 2013
Last updated: February 21, 2014
Last verified: December 2013

February 20, 2013
February 21, 2014
July 2013
December 2015   (final data collection date for primary outcome measure)
Forced expiratory volume in 1-second (FEV1) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01796392 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Adverse Events [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Same as current
 
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Lung Function Improvement After Bronchoscopic Lung Volume Reduction With Pulmonx Endobronchial Valves Used in Treatment of Emphysema

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Emphysema
  • 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.
  • 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.
  • 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.
    Intervention: Device: EBV
  • 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.
    Intervention: Other: Optimal Medical Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
183
December 2018
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical and 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 two or more hospitalizations over the last year for a COPD exacerbation
  • Had two or more 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
Both
40 Years to 75 Years
No
Not Provided
United States
 
NCT01796392
600-0012
Yes
Pulmonx, Inc.
Pulmonx, Inc.
Not Provided
Principal Investigator: Gerard Criner, MD Temple University Hospital, Philadelphia, PA
Principal Investigator: Armin Ernst, MD Reliant Medical Group, Worcester, MA
Pulmonx, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP