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



Status:Active, not recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 75
Updated:3/7/2019
Start Date:July 2013
End Date:February 2023

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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.

Based on the 12-month follow up data from the LIBERATE Study, the Zephyr Endobronchial Valve
System was approved by the FDA for the treatment of severe emphysema in June 2018. Following
this PMA approval, and in agreement with the FDA, the ongoing long term follow-up (out to 5
years) of patients in the LIBERATE Study will now be conducted as a Post-approval study under
the auspices of the "LIBERATE Extension Study". This is an administrative change with
absolutely no change to the design or conduct of the study and, therefore has no material
impact to the study participants or the study sites. All annual follow-up visits and
evaluations are per the original LIBERATE Study protocol. Reporting to the FDA will be as the
LIBERATE Extension Study.

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

- Residual Volume less than 175% predicted (determined by body plethysmography)

- Little or no collateral ventilation (CV-) as determined using the Chartis System

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
We found this trial at
18
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San Francisco, California 94143
Principal Investigator: Steven Hays, MD
Phone: 415-353-7995
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mark Dransfield, MD
Phone: 205-996-5392
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Adnan Majid, MD
Phone: 617-667-4290
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Michael Machuzak, MD
Phone: 216-445-4215
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: M. Paul McFadden, MD
Phone: 323-442-6252
University of Southern California The University of Southern California is one of the world’s leading...
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Mark A Vollenweider, MD, MPH
Phone: 321-841-3685
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Nicholas Pastis, MD
Phone: 843-792-6280
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Momen Wahidi, MD
Phone: 919-668-3812
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Lisa M Kopas, MD
Phone: 713-441-3247
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Louisville, Kentucky 40202
Principal Investigator: Tanya Wiese, DO
Phone: 502-852-0026
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2500 Grant Rd
Mountain View, California 94040
(650) 940-7000
El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Gerard Criner, MD
Phone: 215-707-1559
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Phoenix, Arizona 85013
Principal Investigator: Richard Sue, MD
Phone: 602-240-3383
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Frank Sciurba, MD
Phone: 412-864-3368
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Porto Alegre, RS 90035
Principal Investigator: Hugo G Oliveira, MD
Phone: 55-51-3359-6333
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Brian Morrissey, MD
Phone: 916-734-3351
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Arthur Sung, MD
Phone: 650-723-8222
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Torrance, California 90502
Principal Investigator: David Hsia, MD
Phone: 310-222-8200
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