Trial record 1 of 8 for:    pulmonx
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT01796392
First received: February 20, 2013
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
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.

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 2020
Estimated Primary Completion Date: June 2017 (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.

Detailed Description:

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.

  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
  • 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
  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: Michelle Hernandez, BA, CCRP    323-442-6252    Michelle.Hernandez@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@ucdmc.ucdavis.edu   
Principal Investigator: Brian Morrissey, 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         
Stanford University Recruiting
Stanford, California, United States, 94507
Contact: Susan Jacobs, RN, MS    650-723-8222    ssjpulm@stanford.edu   
Contact: Karen Morris, PhD    650-497-2929    kkmorris@stanford.edu   
Principal Investigator: Arthur Sung, MD         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Letty Diaz    310-222-8200    ldiaz@labiomed.org   
Principal Investigator: David Hsia, MD         
United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Kristine Sernulka    321-841-3685    Kristine.Sernulka@orlandohealth.com   
Contact: Paula Willett, RN    321-841-9623    Paula.Willett@orlandohealth.com   
Principal Investigator: Mark A Vollenweider, MD, MPH         
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
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Wendy Hori, RN    617-667-4290    whori@bidmc.harvard.edu   
Principal Investigator: Adnan Majid, 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, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Yvonne Meli, RN    216-445-4215    MELIY@ccf.org   
Principal Investigator: Michael Machuzak, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Helga Criner, RN, BSN    215-707-1559    Lii-Yoong.Criner@tuhs.temple.edu   
Principal Investigator: Gerard Criner, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christina Ledezma, PhD    412-864-3368    ledezmacm@upmc.edu   
Principal Investigator: Frank Sciurba, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Danielle N Woodford, MS    843-792-6280    woodfordd@musc.edu   
Contact: Gwen Blanton       blantonm@musc.edu   
Principal Investigator: Nicholas Pastis, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Whipple, BSN,RN,CCRC    713-441-3247    mbwhipple@houstonmethodist.org   
Principal Investigator: Lisa M Kopas, MD         
Brazil
Hospital de Clinicas Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Contact: Taiane Vieira, RN, PHD    55-51-3359-6333    tavieira@hcpa.edu.br   
Principal Investigator: Hugo G Oliveira, MD         
INCOR - Hospital das Clinicas de Faculdade de Medicine da USP Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Luciana C Nobrega    55 11 2661 5109    luciana.cassimiro@incor.usp.br   
Principal Investigator: Paulo F Cardoso, MD         
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700
Contact: Karin Klooster       k.klooster@umcg.nl   
Principal Investigator: Dirk-Jan Slebos, MD PhD         
United Kingdom
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Catherine O'Donovan    +44 0 117 342-3872    Catherine.O'Donovan@UHBristol.nhs.uk   
Principal Investigator: Nabil Jarad, MD         
Liverpool Heart and Chest hospital Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Sharon Burnett, RN    +44 0 151 600-1868    Sharon.Burnett@lhch.nhs.uk   
Principal Investigator: Kamlesh Mohan, MD         
Royal Brompton & Harefield NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Contact: Onyinye Diribe    +44 0 20 7351-8021    O.Diribe@rbht.nhs.uk   
Principal Investigator: Pallav Shah, 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

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 29, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 27, 2016