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Spots Global Cancer Trial Database for Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

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Trial Identification

Brief Title: Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

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

Study ID: NCT02684838

Conditions

CNS Tumor

Interventions

Study Description

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

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Spine and Neuro Center, Huntsville, Alabama, United States

Borrow Neurological Institute, Phoenix, Arizona, United States

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center, Scottsdale, Arizona, United States

Neurological Associates of Tucson, DBA Center for Neurosciences, Tucson, Arizona, United States

David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the, Los Angeles, California, United States

University of California, San Francisco Department of Neurological Surgery, San Francisco, California, United States

University of Colorado School of Medicine, Aurora, Colorado, United States

Baycare Medical Group, Tampa, Florida, United States

Emory University Hospital, Atlanta, Georgia, United States

Beacon Medical Group, Elkhart, Indiana, United States

Baptist Health Paducah, Paducah, Kentucky, United States

Oschner Medical Center, New Orleans, Louisiana, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

McLaren Bay Neurology Associates, Bay City, Michigan, United States

Henry Ford Health System, Detroit, Michigan, United States

Depaul Hospital, Bridgeton, Missouri, United States

St. Louis University Hospital, Saint Louis, Missouri, United States

Western Regional Ctr for Brain and Spine Surgery, Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Jfk Medical Center, Edison, New Jersey, United States

Albany Medical Center Hospital, Albany, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Brain Tumor Center, Lake Success, New York, United States

Crouse Neuroscience Institute, Syracuse, New York, United States

Vidant Medical Center, Greenville, North Carolina, United States

Wake Forest Baptist Med Center, Winston-Salem, North Carolina, United States

Mount Carmel Neurosurgery, Columbus, Ohio, United States

University of Oklahoma - Stevenson Cancer Center, Oklahoma City, Oklahoma, United States

University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States

Grand Strand Medical Center, Myrtle Beach, South Carolina, United States

University of Washington School of Medicine, Seattle, Washington, United States

Contact Details

Name: Evan Scullin, MD

Affiliation: Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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