Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
(VIGILANT Trial)
Recruiting at 31 trial locations
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Overseen ByKay Price, PhD, ARNP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Arbor Pharmaceuticals, Inc.
Must be taking: Gliadel Wafer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Research Team
ES
Evan Scullin, MD
Principal Investigator
Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."
Eligibility Criteria
Inclusion Criteria
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.
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.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients receive Gliadel Wafer as part of usual care, with data collected perioperatively
Perioperative period
During hospital stay for primary procedure
Follow-up
Participants are monitored for safety and effectiveness during regular office visits
up to 3 years
Regular office visits
Treatment Details
Interventions
- Gliadel Wafer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arbor Pharmaceuticals, Inc.
Lead Sponsor
Trials
17
Recruited
2,500+
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