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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT01796392
First received: February 20, 2013
Last updated: May 6, 2016
Last verified: May 2016

February 20, 2013
May 6, 2016
July 2013
June 2017   (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 an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

The Pulmonx Zephyr Endobronchial Valve (EBV) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The EBV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

The LIBERATE Study is a clinical trial with two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

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 2020
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical and radiological evidence of emphysema
  • Nonsmoking for 4 months prior to screening interview
  • BMI less than 35 kg/m2
  • 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   (Adult, Senior)
No
United States,   Brazil,   Netherlands,   United Kingdom
 
NCT01796392
600-0012
Yes
Undecided
Not Provided
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.
May 2016

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