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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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: July 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796392

Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Patti Smith, RN, BSN    205-996-5392    psmith@uab.edu   
Contact: Necole Harris    205-934-9240    kanicky@uab.edu   
Principal Investigator: Mark Dransfield, MD         
United States, Arizona
Arizona Pulmonary Specialists Recruiting
Phoenix, Arizona, United States, 85012
Contact: Terry Thomas    602-240-3383    tthomas@azoncology.com   
Principal Investigator: Richard Sue, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Amelia Weldon, MA    323-442-5763    Amelia.Weldon@med.usc.edu   
Principal Investigator: M. Paul McFadden, MD         
University of California at Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Tina Tham    916-734-3351    tina.tham@ucdavis.edu   
Principal Investigator: Andrew Chan, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Anne Powers, RN    619-543-2291    atpowers@ucsd.edu   
Principal Investigator: Samir Makani, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Gabriela Dincheva    415-353-7995    Gabriela.Dincheva@ucsfmedctr.org   
Contact: Archer Eller, MS    415-502-2025    Archer.Eller@ucsf.edu   
Principal Investigator: Steven Hays, MD         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Rafi Kiledjian, MD    310-222-8200    rkiledjian@labiomed.org   
Principal Investigator: David Hsia, MD         
United States, Illinois
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62781
Contact: Theresa Boley    217-545-5000    tboley@siumed.edu   
Principal Investigator: Stephen Hazelrigg, MD         
United States, Kentucky
University of Louisville Research Foundation Recruiting
Louisville, Kentucky, United States, 40202
Contact: Crissie Despirito, RN    502-852-0026    crissie.despirito@louisville.edu   
Principal Investigator: Tanya Wiese, DO         
United States, Massachusetts
St. Elizabeth's Medical Center of Boston Recruiting
Boston, Massachusetts, United States, 02135
Contact: Arthur Dea    617-789-2078    arthur.dea@steward.org   
Contact: Katherine Herrick       katherine.herrick@steward.org   
Principal Investigator: Samaan Rafeq, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Roel-Rolando Almario, RN, BSN    313-916-2433    RAlmari1@hfhs.org   
Contact: Lana Saugrich, RN    313-916-2433    LSAUGRI9@hfhs.org   
Principal Investigator: Michael Simoff, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Emily Smathers    919-668-3812    Emily.Smathers@duke.edu   
Principal Investigator: Momen Wahidi, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Melody Santiago, RN, BSN    215-707-9847    Melody.Santiago@tuhs.temple.edu   
Principal Investigator: Gerard Criner, MD         
United States, Washington
Swedish Thoracic Surgery Recruiting
Seattle, Washington, United States, 98104
Contact: Tina Brennan    206-386-2450    christina.brennan@swedish.org   
Contact: Sean McHugh       sean.mchugh@swedish.org   
Principal Investigator: Jed Gorden, MD         
Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Principal Investigator: Gerard Criner, MD Temple University Hospital, Philadelphia, PA
Principal Investigator: Armin Ernst, MD Reliant Medical Group, Worcester, 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 21, 2014
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 July 28, 2014