EmphysemaIBV®ValveNCT00475007
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
A study testing IBV® Valve System in people with Emphysema and COPD, run by Olympus Corporation of the Americas at 34 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- What is being tested?
- IBV® Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 34 sitesUnited States
- Study dates
- Sep 2007to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Akron General Medical Center
Akron, Ohio, 44307
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Emory HealthCare
Atlanta, Georgia, 30322
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
National Jewish Medical & Research Center
Denver, Colorado, 80206
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007
University of Florida
Gainesville, Florida, 32610
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Kaiser Permanente Medical Center
Los Angeles, California, 90027
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mission Internal Medicine Group
Mission Viejo, California, 92691
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kaiser Permanente Northwest
Portland, Oregon, 97227
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California Davis Medical Center
Sacramento, California, 95817
Health Partners Research Foundation/Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah
Salt Lake City, Utah, 84148
University of Texas Health Science Center
San Antonio, Texas, 78258
University of California San Diego
San Diego, California, 92103
Sarasota Memorial Hospital
Sarasota, Florida, 34239
University of Washington
Seattle, Washington, 98195
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
Pulmonary and Allergy Associates
Summit, New Jersey, 07901
Franciscan Research Center
Tacoma, Washington, 98405
Scott and White Memorial Hospital
Temple, Texas, 76508
Oklahoma State University
Tulsa, Oklahoma, 74127
About this study
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
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.
Read the 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.
- Being tested
- IBV® Valve System
- Keywords
- Emphysema, IBV® Valve, COPD, Shortness of Breath, Spiration
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBV® Valve SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Device: IBV® Valve System |
| 2 | Sham comparator | 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. Receives: Device: IBV® Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
The difference between average 6 minute walk test results for treatment & control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2011
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475007
- Sponsor's protocol ID
- CPR-01377
- Acronym
- IBV®Valve
- Status last verified
- Nov 2017
- First submitted
- 16 May 2007
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25321447
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00475007
- Acronym / sponsor ID
- IBV®Valve / CPR-01377
- Keywords
- Emphysema, IBV® Valve, COPD, Shortness of Breath, Spiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: IBV® Valve SystemThe 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 comparator | Device: IBV® Valve SystemThe 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. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBV® Valve SystemThe 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. | Device | 1, 2 |
Primary outcome
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
1 secondary outcome
The difference between average 6 minute walk test results for treatment & control groups.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 25321447Wood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBV® Valve System in people with Emphysema and COPD, run by Olympus Corporation of the Americas at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.