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.
ClinicalTrials.gov Identifier: NCT02684838
UCLA IRB #: 14-001090
Sponsor: Arbor Pharmaceuticals, Inc.
Time Frame: up to 3 years
Purpose: 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.
Principal Investigator: Linda Liau, MD, PhD, MBA
Contact: Diana Moughon, PhD
Phone: (310) 486-6842