Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
NCT ID: NCT00475007
Last Updated: 2018-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
277 participants
INTERVENTIONAL
2007-09-30
2017-08-31
Brief Summary
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Detailed Description
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The IBV Valve Trial is a randomized, blinded trial. This means that participants are divided into two groups but do not know to which group they have been assigned.
The IBV Valve Treatment Group receives valves, and the Control Group does not. A random selection process decides the group assignments (participants will not be able to choose their group). In the trial, everyone will have a 50 percent chance (similar to a coin toss) to be assigned to one group or the other.
All Participants in this Clinical Trial will:
Receive a diagnostic bronchoscopy that will allow an expert in lung health to evaluate their lungs.
Be under the care of a highly qualified lung doctor for the entire time they are in the trial, regardless of whether they are in the Treatment Group or the Control Group.
Receive regular periodic check-ups and health assessments throughout the 6 month trial period.
The procedure, all testing, and doctor visits are provided at no cost to participants of both the IBV Valve Treatment Group and the Control Group.
At the completion of their 6-month visit, participants will be told if they were assigned to the Treatment Group or the Control Group. If participants were assigned to the group that did not receive valves (the Control Group), they will be given the option to be re-evaluated by the clinical trial doctor, to determine if they can have valve treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
The experimental group will have an investigational medical device implanted in their lungs with an instrument known as a bronchoscope. This procedure is done without an incision
IBV® Valve System
The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
2
The sham comparator group will be tested, treated and followed in an identical manner as the experimental group, except that no valves will be placed during the diagnostic bronchoscopy, the sham procedure.
IBV® Valve System
The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
Interventions
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IBV® Valve System
The IBV Valve is a small, umbrella shaped device designed to redirect airflow to healthier areas of the lungs. It is implanted without incisions using a bronchoscope.
Eligibility Criteria
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Inclusion Criteria
* Must be able to participate in standard exercise testing.
* Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
* Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
* Willing to participate in multiple visits to a medical center for health assessment tests.
* Willing to have a minimum of one overnight stay in the hospital.
Exclusion Criteria
* Unable to tolerate, flexible bronchoscopy procedures.
* Active asthma, chronic bronchitis.
* Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
* Has had prior lung volume reduction surgery.
40 Years
74 Years
ALL
No
Sponsors
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Olympus Corporation of the Americas
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Mission Internal Medicine Group
Mission Viejo, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory HealthCare
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
Health Partners Research Foundation/Regions Hospital
Saint Paul, Minnesota, United States
Pulmonary and Allergy Associates
Summit, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Akron General Medical Center
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma State University
Tulsa, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Franciscan Research Center
Tacoma, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA, Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014 Oct;21(4):288-97. doi: 10.1097/LBR.0000000000000110.
Other Identifiers
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CPR-01377
Identifier Type: -
Identifier Source: org_study_id
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