- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475007
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve)
A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
Study Overview
Detailed Description
The IBV Valve Trial is a multi-center clinical trial evaluating the IBV Valve System, a non-surgical treatment for patients with emphysema. The IBV Valve System does not require traditional surgery or surgical incisions. The valves are placed during a bronchoscopic procedure. The IBV Valve System is designed to redirect airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status. Although the valves are intended to be permanent, they are designed to be removed if necessary.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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California
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Los Angeles, California, United States, 90095
- University of California Los Angeles (UCLA)
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Los Angeles, California, United States, 90027
- Kaiser Permanente Medical Center
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Mission Viejo, California, United States, 92691
- Mission Internal Medicine Group
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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San Diego, California, United States, 92103
- University of California San Diego
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Medical & Research Center
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory Healthcare
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Hospital Network
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Springfield, Illinois, United States, 62794
- Southern Illinois University School of Medicine
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Maryland
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Baltimore, Maryland, United States, 21237
- Pulmonary and Critical Care Associates of Baltimore
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Minnesota
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Saint Paul, Minnesota, United States, 55101
- Health Partners Research Foundation/Regions Hospital
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New Jersey
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Summit, New Jersey, United States, 07901
- Pulmonary and Allergy Associates
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Ohio
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Akron, Ohio, United States, 44307
- Akron General Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Tulsa, Oklahoma, United States, 74127
- Oklahoma State University
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Oregon
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Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Texas
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San Antonio, Texas, United States, 78258
- University of Texas Health Science Center
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- University of Utah
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Tacoma, Washington, United States, 98405
- Franciscan Research Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College Of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Candidates have mostly upper lobe, severe emphysema.
- 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:
- Evidence of another co-existing major medical disease.
- Unable to tolerate, flexible bronchoscopy procedures.
- Active asthma, chronic bronchitis.
- Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
- Has had prior lung volume reduction surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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
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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.
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SHAM_COMPARATOR: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan.
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference between average 6 minute walk test results for treatment & control groups.
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR-01377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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