Clinical Study of a Laser Ablation Procedure for Drug-Resistant Epilepsy PARTICIPATION IN THE SLATE STUDY
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
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A clinical study of a laser ablation procedure for drug-resistant epilepsy is currently enrolling eligible patients who would like to participate. Centers participating in the study will research whether laser ablation is a safe and effective treatment option for certain patients with uncontrolled seizures caused by mesial temporal lobe epilepsy (MTLE).
The SLATE study will use the Medtronic VisualaseTM MRI-guided laser ablation system.
The Visualase system is used to perform minimally invasive laser surgery on soft tissue in the body. For neurosurgery, a surgeon guides a thin laser fiber through a small hole into the brain. The laser heats up and destroys a defined area of abnormal brain tissue, minimizing risk of potential damage to surrounding healthy tissue.
The patient is in a magnetic resonance imaging (MRI) scanner throughout the process. This lets the surgeon see an image of the brain, the laser probe placement, and how much tissue is being heated up and destroyed during the procedure.
Visualase is currently considered an investigational device for treatment of drug-resistant MTLE. The FDA has cleared the use of Visualase in neurosurgery and other surgical specialties.
Visualase MRI-Guided Laser Ablation for Minimally Invasive Neurosurgery
Watch an overview animation of the procedure.
You may qualify to participate in this study if you have mesial temporal lobe epilepsy (MTLE) and uncontrolled seizures. Your epilepsy doctor may have told you about the study and may do some tests to see if you qualify for the study. You may be a candidate if:
To take the next step, please contact a study center for more information. Only a study doctor can decide if you are a candidate for the study.
If you qualify for the study and you decide to participate after learning more about the study, you will go to a study center for several visits:
You must be willing to:
Medtronic will pay for the study device and any tests or procedures done just for the research study. However, you or your insurance company may be billed for any tests and procedures that are considered standard medical care.
A clinical study is a research study that explores whether a medical strategy, treatment, or device is safe and effective for people. These studies are used to produce the best data available for healthcare decision making.
Clinical studies follow strict scientific standards. These standards protect patients and help produce reliable study results. The clinical study may find that a new strategy, treatment, or device improves patient outcomes, offers no benefit, or causes unexpected harm. All of these results are important because they advance medical knowledge and help improve patient care.
Contact one of these study centers to see if you qualify and to learn more. Check back for additional updates on sites.
University of Arizona
David Labiner, MD
Contact: Eddie Soto
Tel : 520-626-3576
Palo Alto, CA
Casey Halpern, MD
Contact 1: Bharati Sanjanwala
Contact 2: Anthony Bet
University of California, San Francisco
San Francisco, CA
Robert Knowlton, MD
Contact: Felicia Kuo
University of Colorado Anschutz Medical Campus
Steven Ojemann, MD
Contact: Pamela David Gerecht, PhD
University of Miami
Jonathan Jagid, MD
Contact: Letitia Fisher
Jon T. Willie, MD, PhD
Contact: Yvan Bamps, PhD
University of Chicago
Peter Warnke, MD
Contact: Justin Bell
Vicenta Salanova, MD
Contact: Abigail Klaehn, RN, BSN
Johns Hopkins University
Joon-Yi Kang, MD
Contact: Tony Stanfield or Joon-Yi Kang
Henry Ford Health System
Jason Schwalb, MD
Contact: Kelly M. Tundo, RN, BSN
Jamie Van Gompel, MD
Contact: Karla Crockett
Rutgers – Robert Wood Johnson Medical School
New Brunswick, NJ
Stephen Wong, MD MS
Contact: Asha Cilly, MSN, FNP-C
Columbia University Medical Center
New York, NY
Guy M. McKhann II MD
Contact: Delma Sosa
Great Neck, NY
Ashesh D. Mehta, MD. PhD
Contact: June Taylor, NP
Wake Forest Baptist Health
Gautam Popli, MD
Contact: Jessica P.
Thomas Jefferson University
Michael Sperling, MD
Contact: Aaron Roberts
University of Texas Health Science Center at Houston
Nitin Tandon, MD
Contact 1: Jessica A Johnson,MSN, NP-C
Contact 2: Susan Pouliot
University of Washington- Harborview Medical Center
John Miller, MD, PhD
Contact: Andrea Oliva, CSP
As with any medical device or procedure, serious and even life-threatening risks and side effects can occur. The risks of this investigational therapy are listed in the informed consent document that potential patients review before participating in the study.
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