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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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.

Keywords

CNS Tumor Gliadel, Carmustine wafer implant Carmustine

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the accepting new patients
    Los Angeles, California, 90095, United States
  • University of California - Irvine accepting new patients
    Orange, California, 92868, United States
  • Western Regional Ctr for Brain and Spine Surgery accepting new patients
    Las Vegas, Nevada, 89102, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arbor Pharmaceuticals, Inc.
ID
NCT02684838
Lead Scientist
NICHOLAS BUTOWSKI
Study Type
Observational
Last Updated
August 1, 2017
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