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Completed

NCT Number: NCT02684838

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spine and Neuro Center, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To evaluate the overall survival rate for patients treated with Gliadel Wafer

    Time frame: up to 3 years

    Time from Gliadel placement to death

  2. 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

  3. 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

Secondary outcomes

  1. To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.

    Time frame: up to 3 years

    Frequency of SAEs

  2. To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.

    Time frame: up to 3 years

    Frequency of EOIs

  3. To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.

    Time frame: up to 3 years

    frequency of ADRs

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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

  2. To explore patient survival status based upon biomarker status.

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

Arbor Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: VIGILANT

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2016
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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