Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Completed

Conditions studied: CNS Tumor

In brief

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

Key facts

Study ID

NCT02684838

Run by

Arbor Pharmaceuticals, Inc.

People needed

272

Starts

2016-04-26

Expected to finish

2025-06-23

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
• Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

Where it is running

• Spine and Neuro Center — Huntsville, Alabama, United States
• Borrow Neurological Institute — Phoenix, Arizona, United States
• Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center — Scottdale, Arizona, United States
• Neurological Associates of Tucson, DBA Center for Neurosciences — Tucson, Arizona, United States
• David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the — Los Angeles, California, United States
• University of California, San Francisco Department of Neurological Surgery — San Francisco, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• Baycare Medical Group — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Beacon Medical Group — Elkhart, Indiana, United States
• Baptist Health Paducah — Paducah, Kentucky, United States
• Oschner Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• McLaren Bay Neurology Associates — Bay City, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Depaul Hospital — Bridgeton, Missouri, United States
• St. Louis University Hospital — St Louis, Missouri, United States
• Western Regional Ctr for Brain and Spine Surgery — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Jfk Medical Center — Edison, New Jersey, United States
• Albany Medical Center Hospital — Albany, New York, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Brain Tumor Center — Lake Success, New York, United States
• Crouse Neuroscience Institute — Syracuse, New York, United States
• Vidant Medical Center — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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