Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)
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ClinicalTrials.gov Identifier: NCT02684838 |
Recruitment Status :
Recruiting
First Posted : February 18, 2016
Last Update Posted : February 16, 2022
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Condition or disease |
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CNS Tumor |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | April 26, 2016 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

- To evaluate the overall survival rate for patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]Time from Gliadel placement to death
- To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]Time from Gliadel placement to death due to CNS tumor
- To evaluate the progression-free survival rate for patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]Time from Gliadel placement to diagnosis of recurrent CNS tumor
- To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]Frequency of SAEs
- To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]Frequency of EOIs
- To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. [ Time Frame: up to 3 years ]frequency of ADRs
- To evaluate change in patient health status over time via patient reported outcomes (PRO) [ Time Frame: up to 3 years ]Change in FACT-Br score from baseline to end of study participation
- To evaluate change in patient health status over time via a practitioner/proxy reported scale [ Time Frame: up to 3 years ]Change in KPS score from baseline to end of study participation
- To evaluate the the reasons a physician does not insert Gliadel Wafers, in patients who were considered and consented for this Registry prior to the tumor resection procedure [ Time Frame: up to 3 years ]reasons for screen failure
- To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer [ Time Frame: up to 3 years ]number of days in hospital following Gliadel insertion
- To explore patient survival status based upon biomarker status. [ Time Frame: up to 3 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684838
Contact: Kay Price, PhD, ARNP | 859-229-6376 | Kay.Price@iconplc.com | |
Contact: Tania D Johnson, RN, BSN | 404-496-5903 | TANIA.JOHNSON@AZURITY.COM |

Study Chair: | Evan Scullin, MD | Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc." |
Responsible Party: | Arbor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02684838 |
Other Study ID Numbers: |
AR22-001 |
First Posted: | February 18, 2016 Key Record Dates |
Last Update Posted: | February 16, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gliadel, Carmustine wafer implant |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |