This is a randomized, double-blind, clinical research
study designed to evaluate the safety and efficacy of the airway
bypass procedure for the treatment of homogeneous emphysema.
The minimum requirements for participation in the trial are that
you:
- Are age 35 years or older
- Have been diagnosed with advanced widespread emphysema
- Have stopped smoking at least 2 months before entering the trial
These are only the basic conditions. There are other requirements
that you will be asked about if you choose to complete the
EASE Trial screening questionnaire.
The steps involved in the trial are outlined
in the diagram and further described below.
(click on any area of the diagram for a more detailed description
of that step)
Patient Consent
If you are interested in participating in this research trial, you
will be given a document called the "Informed Consent"
form. You should read the entire document very carefully and ask
questions about anything you do not understand. Informed consent
involves a discussion with the clinical investigators related to
the procedure and potential risks and benefits of the clinical research
study. The Study Coordinator or doctor will be available to explain
why the trial is being done and what you can expect. If you decide
to participate in the trial, you will be asked to sign the Informed
Consent form. Your signature on the form is your agreement to be
in the trial. If you change your mind about the trial after you
sign the form, you can stop your participation at any time. Your
decision to be in the trial or not, or to quit the trial later on,
will not affect your regular medical care in anyway.
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Screening Tests
After you have signed the document you will have some medical exams.
These exams are called "screening tests" and include things
such as breathing tests, a chest x-ray, a computed tomography (CT
also called a CAT) scan of your lungs, a physical examination, and
other medical assessments. These exams will be used to see if you
meet the requirements for the trial, but they will also serve to
compare your condition before and after the treatment.
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Supervised Pulmonary Rehabilitation
If your exam results meet the criteria for the trial, you will begin
supervised pulmonary rehabilitation therapy. During pulmonary rehabilitation
you will receive individualized education and exercises to help
you with your emphysema. You will need to complete 16 to 20 therapy
sessions at a clinic over a period of 6 to 10 weeks.
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Baseline Tests
After you have finished the pulmonary rehabilitation therapy, you
will come back for another set of medical exams. The tests at this
interval are called "baseline tests" and include some
of the same tests you had at screening. The baseline exams are done
to record your health status and verify that you still meet the
study requirements necessary to have the procedure.
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Randomization
At this point you will be scheduled for your procedure. We do no
know if you will be randomized to receive the airway bypass procedure
or if you will be in the control group. Regardless of which group
you are in, you will have a medical procedure known as bronchoscopy.
This requires a one-day stay in a hospital. The procedure is conducted
while you are under anesthesia (asleep) and involves placing a long,
thin tube with a light and lens from your nose or mouth, down your
throat and into the airway.
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Bronchoscopy with Bacterial Assessment
A smaller group - one out of three (1/3) participants - will be
the "control" group. If you are in the control group,
you will have bronchoscopy, but new passages will not be made and
stents will not be implanted. The health of the control group will
be closely monitored, and the results will be compared to the group
receiving the airway bypass procedure, enabling researchers to conclude
if there was any benefit from the treatment.
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Bronchoscopy with Stent Placement
Two out of three (2/3) of the participants in the trial will be
in the airway bypass group, or "treatment" group. If you
are in the treatment group, you will undergo the airway bypass procedure
with up to six drug-eluting stents implanted in your lungs, creating
the passageways for the trapped air to escape.
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Supervised Pulmonary Rehabilitation
After the procedure and a few tests and questionnaires, you will
begin another series of 8-9 weeks of pulmonary rehabilitation sessions
at the same clinic you went to the first time.
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Follow-up Visits
You will also need to return to the study center four times during
the year for follow-up visits and tests. During the follow-up visits
you will have some medical exams to look for changes in your lungs.
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Complete Study / Annual Evaluations
All participants will be told which group they were in when they
come back for a follow-up visit one year after the procedure. If
you were in the control group, you will be finished with the trial.
If you were in the treatment group, you will have a follow-up visit
once a year for the next four years to monitor the longer term effects
of the airway bypass procedure.
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