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Clinical Trial Finder

Search Results

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02684838
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arbor Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evan Scullin, MD
Principal Investigator Affiliation Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc."
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CNS Tumor
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spine and Neuro Center, Huntsville, Alabama

Status

Address

Spine and Neuro Center

Huntsville, Alabama, 35801

Borrow Neurological Institute, Phoenix, Arizona

Status

Address

Borrow Neurological Institute

Phoenix, Arizona, 85013

Scottsdale, Arizona

Status

Address

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251

Tucson, Arizona

Status

Address

Neurological Associates of Tucson, DBA Center for Neurosciences

Tucson, Arizona, 85718

Los Angeles, California

Status

Address

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

Los Angeles, California, 90095

San Francisco, California

Status

Address

University of California, San Francisco Department of Neurological Surgery

San Francisco, California, 94143

Aurora, Colorado

Status

Address

University of Colorado School of Medicine

Aurora, Colorado, 80045

Baycare Medical Group, Tampa, Florida

Status

Address

Baycare Medical Group

Tampa, Florida, 33607

Emory University Hospital, Atlanta, Georgia

Status

Address

Emory University Hospital

Atlanta, Georgia, 30322

Beacon Medical Group, Elkhart, Indiana

Status

Address

Beacon Medical Group

Elkhart, Indiana, 46530

Baptist Health Paducah, Paducah, Kentucky

Status

Address

Baptist Health Paducah

Paducah, Kentucky, 42003

Oschner Medical Center, New Orleans, Louisiana

Status

Address

Oschner Medical Center

New Orleans, Louisiana, 70121

Baltimore, Maryland

Status

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

McLaren Bay Neurology Associates, Bay City, Michigan

Status

Address

McLaren Bay Neurology Associates

Bay City, Michigan, 48707

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202

Depaul Hospital, Bridgeton, Missouri

Status

Address

Depaul Hospital

Bridgeton, Missouri, 63044

St. Louis University Hospital, Saint Louis, Missouri

Status

Address

St. Louis University Hospital

Saint Louis, Missouri, 63110

Las Vegas, Nevada

Status

Address

Western Regional Ctr for Brain and Spine Surgery

Las Vegas, Nevada, 89102

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Jfk Medical Center, Edison, New Jersey

Status

Address

Jfk Medical Center

Edison, New Jersey, 08820

Albany Medical Center Hospital, Albany, New York

Status

Address

Albany Medical Center Hospital

Albany, New York, 12208

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Brain Tumor Center, Lake Success, New York

Status

Address

Brain Tumor Center

Lake Success, New York, 11042

Crouse Neuroscience Institute, Syracuse, New York

Status

Address

Crouse Neuroscience Institute

Syracuse, New York, 13210

Vidant Medical Center, Greenville, North Carolina

Status

Address

Vidant Medical Center

Greenville, North Carolina, 27834

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

Status

Address

Wake Forest Baptist Med Center

Winston-Salem, North Carolina, 27157

Mount Carmel Neurosurgery, Columbus, Ohio

Status

Address

Mount Carmel Neurosurgery

Columbus, Ohio, 43222

Oklahoma City, Oklahoma

Status

Address

University of Oklahoma - Stevenson Cancer Center

Oklahoma City, Oklahoma, 73104

University of Pennsylvania Health System, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104

Grand Strand Medical Center, Myrtle Beach, South Carolina

Status

Address

Grand Strand Medical Center

Myrtle Beach, South Carolina, 39572

Seattle, Washington

Status

Address

University of Washington School of Medicine

Seattle, Washington, 98195

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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