Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:5/27/2018
Start Date:March 2016
End Date:December 2023
Contact:Kim Petranick, BA, MS
Email:Vigilant@MapiGroup.com
Phone:800-381-7878

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Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice

This is a prospective, observational registry in patients who have been prescribed Gliadel
Wafer by the physician as part of usual care.

This is a prospective, observational registry in patients who have been prescribed Gliadel
Wafer by the physician as part of usual care. Data will be collected on the safety and
effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular
office visits up to 3-years. Patients enrolled in this registry will be asked to complete a
questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their
well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office
visits.

Inclusion Criteria:

1. Signed informed consent, by the patient or a legally acceptable representative,
obtained before any registry-related activities are undertaken. The informed consent
must be signed within 14 calendar days after surgery.

2. Male and female patients, greater than or equal to 18 years of age or age of majority
in state of residence.

3. Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer
and having signed consent to enroll in the registry within 14 calendar days after
surgery for treatment of central nervous system (CNS) tumor(s), or are currently
enrolled in another study where they received Gliadel Wafer.

4. Signed release form, by the patient or a legally acceptable representative, permitting
abstraction of the patient's medical records at Baseline and during participation in
the registry.

Exclusion Criteria:

1. The patient is enrolled in an interventional clinical trial, in which treatment for
CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment.

2. Any abnormality or medical condition that, at the discretion of the Investigator, may
put the patient at increased risk by participating in this registry.

3. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to
participate in this registry.
We found this trial at
36
sites
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: KAISORN CHAICHANA, MD
Phone: 410-502-8273
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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43 New Scotland Avenue
Albany, New York 12208
Principal Investigator: JOHN DALFINO, MD
Phone: 518-262-5938
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Albany, NY
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: ANDREW FABIANO, MD
Phone: 716-845-4516
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: ALLEN SILLS, MD
Phone: 615-936-4470
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Atlanta, Georgia 30033
Principal Investigator: CORY ADAMSON, MD
Phone: 478-998-8244
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Atlanta, GA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: JEFFREY J OLSON, MD
Phone: 404-778-2981
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Kevin O Lillehei, MD
Phone: 303-724-1995
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Aurora, CO
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4175 North Euclid Avenue
Bay City, Michigan 48707
Principal Investigator: Sunil Manjila, MD
Phone: 989-894-3290
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12303 De Paul Drive
Bridgeton, Missouri 63044
Principal Investigator: DANIEL SCODARY, MD
Phone: 309-241-1047
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Clearwater, Florida 33756
Principal Investigator: CARRIE SHULMAN, MD
Phone: 727-462-3764
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750 Mount Carmel Mall
Columbus, Ohio 43222
Principal Investigator: Arthur Cole, MD
Phone: 614-234-5814
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Columbus, OH
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Detroit, Michigan 48202
Principal Investigator: STEVEN KALKANIS, MD
Phone: 313-916-1340
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Edison, New Jersey
Principal Investigator: Stephen M Bloomfield, MD
Phone: 732-321-7000
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6913 North Main Street
Elkhart, Indiana 46530
Principal Investigator: Joseph Schnittker, MD
Phone: 574-294-8404
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Greenville, North Carolina 27834
Principal Investigator: STUART LEE, MD
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Huntsville, Alabama 35801
Principal Investigator: Rhett Murray, MD
Phone: 256-533-8081
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Lake Success, New York 11042
Principal Investigator: MIKE SCHULDER, MD
Phone: 516-941-1263
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Las Vegas, Nevada 89109
Principal Investigator: William Smith, MD
Phone: 702-851-5413
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Timothy Ryken, MD
Phone: 603-650-5109
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Los Angeles, California 90095
Principal Investigator: Linda Liau, MD
Phone: 310-794-4223
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809 82nd Parkway
Myrtle Beach, South Carolina 39572
Principal Investigator: JOSEPH CHEATLE, MD
Phone: 843-429-0199
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New Orleans, Louisiana 70121
Principal Investigator: MARCUS WARE, MD
Phone: 504-842-8769
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Oklahoma City, Oklahoma 73104
Principal Investigator: JAMES BATTISTE, MD
Phone: 405-271-8777
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Orange, California 92868
Principal Investigator: Jose Carrillo, MD
Phone: 714-456-8442
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Paducah, Kentucky 42003
Principal Investigator: THOMAS GRUBER, ND
Phone: 270-575-2174
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Philadelphia, Pennsylvania 19104
Principal Investigator: STEVEN BREM, MD
Phone: 215-662-7818
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Phoenix, Arizona 85013
Principal Investigator: LYNN S ASHBY, MD
Phone: 602-406-2141
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Phoenix, Arizona 85054
Principal Investigator: Marcij Mrugala, MD
Phone: 480-301-8100
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3635 Vista Avenue
Saint Louis, Missouri 63110
Principal Investigator: JEROEN COPPENS, MD
Phone: 314-977-4751
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San Francisco, California 94143
Principal Investigator: NICHOLAS BUTOWSKI, MD
Phone: 415-514-5521
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3621 North Wells Fargo Avenue
Scottsdale, Arizona 85251
Principal Investigator: JOHN WANEBO, MD
Phone: 480-882-5564
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Seattle, Washington 98195
Principal Investigator: LYNN TAYLOR, MD
Phone: 206-616-4925
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Syracuse, New York 13210
Principal Investigator: GREG CANUTE, MD
Phone: 315-472-4701
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Tampa, Florida 33614
Principal Investigator: SAMY ELHAMMADY, MD
Phone: 813-356-7168
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Tucson, Arizona 85718
Principal Investigator: Abhay Sanan, MD
Phone: 520-795-7750
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Winston-Salem, North Carolina 27157
Principal Investigator: STEPHEN TATTER, MD
Phone: 336-716-3842
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