Researchers at Sentara
Cardiovascular Research Institute begin a new international study to
explore the safety and effectiveness of stents to open airways of
patients with advanced emphysema or Chronic Obstructive Pulmonary
Disease (COPD).
The EASE (Exhale Airway Stents for Emphysema) Trial focuses on airway
bypass, an investigational technique without surgery to create new
pathways to release trapped air from within diseased lung tissue,
thereby helping patients with advanced widespread emphysema breathe
easier.
Similar to the stents used to prop open clogged arteries in heart
patients, these drug-eluting stents are now holding open new
passageways in the lungs.
Pulmonologists and cardiothoracic surgeons at Sentara Thoracic
Surgery Center in Norfolk, Virginia are collaborating to perform this
investigational procedure of the first wave of Virginia participants.
During the procedure, a tube is guided through the mouth of trial
participants to access the lung and implant up to six stents smaller
than a pencil eraser. The goal is to relieve breathlessness and over
inflated lungs -- hallmarks of this incurable, progressive disease.
Traditional treatment options for patients with severe emphysema are
limited to lung reduction surgery, lung transplant, and inhalers,
which have diminishing impact as the disease progresses. Airway
bypass, done without open surgery, is considered minimally invasive
and hoped to be an option for broader numbers of patients.
"Emphysema is really life limiting. Some of my patients who golfed a
year ago now get winded taking a shower," says cardiothoracic surgeon
Joseph Newton, Sentara Cardiovascular Research Institute's principal
investigator for this trial. "Through research like this, I'm hopeful
we are going to find a way to help these patients do things most of
us take for granted," he continues.
That's just what trial candidate John Woodard is hoping for. The
61-year-old Suffolk resident is being evaluated Tuesday, September 22
at Sentara to begin the enrollment process.
"I don't look sick," says Woodard. "You wouldn't know any better
until you saw me exercise," continues Woodard who ran 35 miles each
week up until about 10 years ago. Woodard retired a year ago because
of his condition. "I still play golf, but I have to bring my oxygen
with me," he says.
"Research like this gives new hope of a longer-term solution for more
people. Transplant is not a practical option for a lot of people with
severe emphysema," says Dr. Carolyn Fruci, pulmonologist and critical
care specialist involved in the study. "What's exciting is the
possibility of patients regaining some of the everyday freedoms lost
to this disease," Fruci continues.
Transplant, one of the only treatments today for patients with severe
emphysema, is not plausible for every patient. Participation in this
trial does not prevent patients from being considered for lung
transplantation at a later time.
For Woodard, who has been coping with COPD for the last 10 years,
participating in this research offers hope. "I'm up for most
anything. Naturally if there's any benefit -- to me or anybody else --
that would be wonderful," say Woodard, who is being evaluated for
participation in the trial.
About the Study
The EASE Trial, sponsored by stent maker Broncus Technologies, is a
double blind, sham-controlled, randomized study to evaluate the safety
and effectiveness of a new procedure called airway bypass, which was
first shown to be feasible in 2003.
Sentara Cardiovascular Research Institute, in conjunction with
Sentara Thoracic Surgery Center, is one of only 24 U.S. locations
involved in this trial to date and is currently enrolling patients.
Minimum requirements for participation in the EASE Trial stipulate
that participants are 35 years or older, have been diagnosed with
advanced, widespread emphysema, and have stopped smoking at least two
months prior to entering the trial. Involvement in the study will
last from approximately 15 months up to 5 years (depending on if the
patient is randomized to the control or the treatment group) and
include 8 to 16 physician appointments. All study-related medical
procedures will be carried out at no charge to the patient and
patients will be closely monitored throughout the trial. These are
only the basic conditions for participation and patients are asked
about other conditions before enrolling. For more information please
call 866-431-3273 or visit EASEtrialUS
Results from the open-label Exhale Drug-Eluting Stent feasibility
study were published in the October issue of the Journal of Thoracic
and Cardiovascular Surgery. Positive results included a statistically
significant reduction in the amount of air trapped in the lungs and
an improvement in breathing for patients at six months after the
airway bypass procedure.
Cardiovascular Research Institute begin a new international study to
explore the safety and effectiveness of stents to open airways of
patients with advanced emphysema or Chronic Obstructive Pulmonary
Disease (COPD).
The EASE (Exhale Airway Stents for Emphysema) Trial focuses on airway
bypass, an investigational technique without surgery to create new
pathways to release trapped air from within diseased lung tissue,
thereby helping patients with advanced widespread emphysema breathe
easier.
Similar to the stents used to prop open clogged arteries in heart
patients, these drug-eluting stents are now holding open new
passageways in the lungs.
Pulmonologists and cardiothoracic surgeons at Sentara Thoracic
Surgery Center in Norfolk, Virginia are collaborating to perform this
investigational procedure of the first wave of Virginia participants.
During the procedure, a tube is guided through the mouth of trial
participants to access the lung and implant up to six stents smaller
than a pencil eraser. The goal is to relieve breathlessness and over
inflated lungs -- hallmarks of this incurable, progressive disease.
Traditional treatment options for patients with severe emphysema are
limited to lung reduction surgery, lung transplant, and inhalers,
which have diminishing impact as the disease progresses. Airway
bypass, done without open surgery, is considered minimally invasive
and hoped to be an option for broader numbers of patients.
"Emphysema is really life limiting. Some of my patients who golfed a
year ago now get winded taking a shower," says cardiothoracic surgeon
Joseph Newton, Sentara Cardiovascular Research Institute's principal
investigator for this trial. "Through research like this, I'm hopeful
we are going to find a way to help these patients do things most of
us take for granted," he continues.
That's just what trial candidate John Woodard is hoping for. The
61-year-old Suffolk resident is being evaluated Tuesday, September 22
at Sentara to begin the enrollment process.
"I don't look sick," says Woodard. "You wouldn't know any better
until you saw me exercise," continues Woodard who ran 35 miles each
week up until about 10 years ago. Woodard retired a year ago because
of his condition. "I still play golf, but I have to bring my oxygen
with me," he says.
"Research like this gives new hope of a longer-term solution for more
people. Transplant is not a practical option for a lot of people with
severe emphysema," says Dr. Carolyn Fruci, pulmonologist and critical
care specialist involved in the study. "What's exciting is the
possibility of patients regaining some of the everyday freedoms lost
to this disease," Fruci continues.
Transplant, one of the only treatments today for patients with severe
emphysema, is not plausible for every patient. Participation in this
trial does not prevent patients from being considered for lung
transplantation at a later time.
For Woodard, who has been coping with COPD for the last 10 years,
participating in this research offers hope. "I'm up for most
anything. Naturally if there's any benefit -- to me or anybody else --
that would be wonderful," say Woodard, who is being evaluated for
participation in the trial.
About the Study
The EASE Trial, sponsored by stent maker Broncus Technologies, is a
double blind, sham-controlled, randomized study to evaluate the safety
and effectiveness of a new procedure called airway bypass, which was
first shown to be feasible in 2003.
Sentara Cardiovascular Research Institute, in conjunction with
Sentara Thoracic Surgery Center, is one of only 24 U.S. locations
involved in this trial to date and is currently enrolling patients.
Minimum requirements for participation in the EASE Trial stipulate
that participants are 35 years or older, have been diagnosed with
advanced, widespread emphysema, and have stopped smoking at least two
months prior to entering the trial. Involvement in the study will
last from approximately 15 months up to 5 years (depending on if the
patient is randomized to the control or the treatment group) and
include 8 to 16 physician appointments. All study-related medical
procedures will be carried out at no charge to the patient and
patients will be closely monitored throughout the trial. These are
only the basic conditions for participation and patients are asked
about other conditions before enrolling. For more information please
call 866-431-3273 or visit EASEtrialUS
Results from the open-label Exhale Drug-Eluting Stent feasibility
study were published in the October issue of the Journal of Thoracic
and Cardiovascular Surgery. Positive results included a statistically
significant reduction in the amount of air trapped in the lungs and
an improvement in breathing for patients at six months after the
airway bypass procedure.
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