Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema (IBV®Valve)
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Purpose
This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.
| Condition | Intervention | Phase |
|---|---|---|
|
Emphysema COPD |
Device: IBV® Valve System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema |
- 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 ] [ Designated as safety issue: Yes ]
- The difference between average 6 minute walk test results for treatment & control groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Device: 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.
|
|
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.
|
Device: 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.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California Los Angeles (UCLA) | |
| Los Angeles, California, United States, 90095 | |
| Kaiser Permanente Medical Center | |
| Los Angeles, California, United States, 90027 | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| University of California San Diego | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| National Jewish Medical & Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| United States, Georgia | |
| Emory HealthCare | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Alexian Brothers Hospital Network | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Pulmonary and Critical Care Associates of Baltimore | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Minnesota | |
| Health Partners Research Foundation/Regions Hospital | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, New Jersey | |
| Pulmonary and Allergy Associates | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Oklahoma State University | |
| Tulsa, Oklahoma, United States, 74127 | |
| United States, Oregon | |
| Kaiser Permanente Northwest | |
| Portland, Oregon, United States, 97227 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital | |
| Allentown, Pennsylvania, United States, 18103 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78258 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84148 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Franciscan Research Center | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
More Information
No publications provided
| Responsible Party: | Spiration, Inc. |
| ClinicalTrials.gov Identifier: | NCT00475007 History of Changes |
| Other Study ID Numbers: | CPR-01377 |
| Study First Received: | May 16, 2007 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Spiration, Inc.:
|
Emphysema IBV® Valve COPD Shortness of Breath Spiration |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pulmonary Disease, Chronic Obstructive Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on May 16, 2013