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
1 other identifier
interventional
277
1 country
34
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedApril 17, 2018
November 1, 2017
3.4 years
May 16, 2007
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
The difference between average 6 minute walk test results for treatment & control groups.
6 months
Study Arms (2)
1
EXPERIMENTALThe 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
2
SHAM COMPARATORThe 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Kaiser Permanente Medical Center
Los Angeles, California, 90027, United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Mission Internal Medicine Group
Mission Viejo, California, 92691, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of California San Diego
San Diego, California, 92103, United States
National Jewish Medical & Research Center
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Emory HealthCare
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237, United States
Health Partners Research Foundation/Regions Hospital
Saint Paul, Minnesota, 55101, United States
Pulmonary and Allergy Associates
Summit, New Jersey, 07901, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma State University
Tulsa, Oklahoma, 74127, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Texas Health Science Center
San Antonio, Texas, 78258, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
University of Utah
Salt Lake City, Utah, 84148, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University of Washington
Seattle, Washington, 98195, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 25321447DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2007
First Posted
May 17, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2011
Study Completion
August 1, 2017
Last Updated
April 17, 2018
Record last verified: 2017-11