Zuragen™ Clinic Poster
Local Article Example
Q & A
Educational Incentive Program
CRF Re-order Form
CRF Helpful Hints
Hemodialysis Catheter (Material) Types
Temperature Conversion Chart
AAT-023 Clinical Trial
Issue 1, August 1, 2006
We’re on our way!
It is hard to believe that
eight years have passed since we began the work which led us to this,
our pivotal clinical trial for our AAT-023 product. This is indeed
a very exciting time for Ash Access Technology, and we are grateful
for you and your contributions to this effort.
As you know, bringing
medical devices through conception, design, trials and regulatory
approval is no small task. Yet when the team believes it has a product
which provides a real solution to real-world problems, it can accomplish
such bold goals… and our team believes just that.
Each of us
in this business has a heart for the challenges ESRD patients face.
In addition to the struggle to maintain a patient’s health
through the disease’s complications, the
issues that arise from the treatment itself add to those challenges.
Catheter-related bloodstream infections is one of the most prevalent
problems for hemodialysis patients using chronic central venous catheters.
We believe that AAT-023 will effectively address this problem, thereby
making a significant contribution to the health and well-being of
these patients we serve.
To our knowledge, ours is the first clinical
trial protocol approved by the FDA to examine the safety and effectiveness
of an antimicrobial/antithrombotic catheter therapy such as this.
Our excitement is only increased by the feedback we have received
from the National Institute of Health in its review of our grant
application for this trial (see inset below).
So, now is the
time. On July 17th, our first patient started treatment on the trial
in Lafayette, Indiana. Bakersfield, California has brought three
more in their early efforts...and now, just 396 more to go! We have
worked diligently to not only design a good product, but we have
worked equally hard to put together a world-class team to execute
our trial. And to you, the members of that team, we say “Welcome.” You
can expect us to bring the resources necessary to successfully complete
this trial. We have included a roster of our trial management team
on the second page of this newsletter. We need your expertise and
strong support to enroll patients, execute the trial protocol and
complete the appropriate data reporting. This newsletter will serve
as one source of information for trial updates and enrollment status
to assist you in your efforts. We’re also planning to
highlight each of your research sites. Stay tuned, there will be
more to follow throughout the course of the trial.
From all of us at Ash Access Technology,
we are glad you’re on
the team, and we look forward to working with you in the months ahead!
President & CEO
Chairman of the Board
Director of R&D
Roland K. Winger
Engineering & QA
A quote from the NIH review panel:
“There is no question
that the use of tunneled central venous catheters will not
disappear, since it provides a quick and generally reliable
temporary access for dialysis… About 9% of patients develop
catheter-related bacteremia per month… and
nearly all will have an episode of CRBSI within 6 months.
mortality associated with CRBSI are significant… Development
of a safe and effective antimicrobial and antithrombotic solution
would represent an important advance in the management of patients
is therefore considered highly significant."
|Dr. Kopelman, Bakersfield, CA
|Dr. Al-Makki, Lafayette, IN
|Dr. Block, Denver, CO
|Dr. Fadem, Houston, TX
|Dr. Hariachar, Hudson, FL
|Dr. Henriquez, Bronx, NY
|Dr. Khwaja, Whittier, CA
|Dr. Posner, Baltimore, MD
|Dr. Rogers, Ocala, FL
|Dr. Stephanz, Provo, UT
Trial Management Team:
Averion (Trial Management and
Rita DeVico, CCRA
Jimmy Brown, CPA
Sean Darcy, RN
Christie Morgan, CRA
Elizabeth Morrison, CRA
Holly Vidrine, RN, CRA
Steve Schmitz, MD
StatKing Consulting (Data Management)
Marla Hoelle, RN
Dennis King, PhD
Linda Francisco, MD
Monnie Wasse, MD, MPh
DaVita Clinical Research
Amy Young, CCRC
Deb Coffey, LPN
Lynnelle Murrell, RN, CCRP
National Institute of Clinical Research
Tarek Dessouky, MD
Joél Barra, CRC
Regulatory Affairs Associates
Steven Goldner, JD, RAC
Ash Access Technology, Inc.
Roland Winger, PE
Did you know?
The AAT-023 study protocol specifies that the data
required for screening patients is obtained from the patient’s
regular monthly lab. It is required that patients be enrolled no
more than 14 days after the labs are drawn. As most sites run all
of their patients’ monthly labs at the same time, it is important
to focus on what we call “The 14 Day Window.” This window
makes it extremely important to consent, screen and make ready a
full slate of patients in anticipation of that month’s upcoming
lab draw. Once the 14 Day Window closes for that month, new enrollments
must wait until the following month.
As with all trials, the quality
and pace of enrollment are two critical items for success. Please
let us know how we can support you in your enrollment efforts. Also,
feel free to share your thoughts on how to optimize the 14 Day Window.