Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

NCT ID: NCT02684838

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-26

Study Completion Date

2025-06-23

Brief Summary

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

Detailed Description

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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.

Conditions

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CNS Tumor

Keywords

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Gliadel, Carmustine wafer implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbor Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Spine and Neuro Center

Huntsville, Alabama, United States

Site Status

Borrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

Scottdale, Arizona, United States

Site Status

Neurological Associates of Tucson, DBA Center for Neurosciences

Tucson, Arizona, United States

Site Status

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the

Los Angeles, California, United States

Site Status

University of California, San Francisco Department of Neurological Surgery

San Francisco, California, United States

Site Status

University of Colorado School of Medicine

Aurora, Colorado, United States

Site Status

Baycare Medical Group

Tampa, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Beacon Medical Group

Elkhart, Indiana, United States

Site Status

Baptist Health Paducah

Paducah, Kentucky, United States

Site Status

Oschner Medical Center

New Orleans, Louisiana, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

McLaren Bay Neurology Associates

Bay City, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Depaul Hospital

Bridgeton, Missouri, United States

Site Status

St. Louis University Hospital

St Louis, Missouri, United States

Site Status

Western Regional Ctr for Brain and Spine Surgery

Las Vegas, Nevada, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Jfk Medical Center

Edison, New Jersey, United States

Site Status

Albany Medical Center Hospital

Albany, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Brain Tumor Center

Lake Success, New York, United States

Site Status

Crouse Neuroscience Institute

Syracuse, New York, United States

Site Status

Vidant Medical Center

Greenville, North Carolina, United States

Site Status

Wake Forest Baptist Med Center

Winston-Salem, North Carolina, United States

Site Status

Mount Carmel Neurosurgery

Columbus, Ohio, United States

Site Status

University of Oklahoma - Stevenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Grand Strand Medical Center

Myrtle Beach, South Carolina, United States

Site Status

University of Washington School of Medicine

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Lillehei 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.

Reference Type DERIVED
PMID: 29206049 (View on PubMed)

Other Identifiers

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AR22.001

Identifier Type: -

Identifier Source: org_study_id