Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema - NCT00475007-92103 (Clinical Trial 170260)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy170260.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92103 |
| Conditions: |
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Emphysema - COPD |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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University of California San Diego
San Diego, CA 92103
United States
Primary Contact:
Barbara Munden, RN
Email: bmunden@ucsd.edu
Phone: 619-543-7963 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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