Clinical trial · Observational
Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
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
NCT02684838CI-TRIAL-00097100VIGILANTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To evaluate the overall survival rate for patients treated with Gliadel Wafer
- timeFrame
- up to 3 years
- description
- Time from Gliadel placement to death
- measure
- To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer
- timeFrame
- up to 3 years
- description
- Time from Gliadel placement to death due to CNS tumor
- measure
- To evaluate the progression-free survival rate for patients treated with Gliadel Wafer
- timeFrame
- up to 3 years
- description
- Time from Gliadel placement to diagnosis of recurrent CNS tumor
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLillehei KO, Kalkanis SN, Liau LM, Mydland DE, Olson J, Paleologos NA, Ryken T, Johnson T, Scullin E. Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry. CNS Oncol. 2018 Apr;7(2):CNS08. doi: 10.2217/cns-2017-0036. Epub 2017 Dec 5. PMID 29206049