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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 4068590, Alabama 4829764

Status

Address

Spine and Neuro Center

Huntsville 4068590, Alabama 4829764, 35801

Borrow Neurological Institute, Phoenix 5308655, Arizona 5551752

Status

Address

Borrow Neurological Institute

Phoenix 5308655, Arizona 5551752, 85013

Scottdale, Arizona 5551752

Status

Address

Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center

Scottdale, Arizona 5551752, 85251

Tucson 5318313, Arizona 5551752

Status

Address

Neurological Associates of Tucson, DBA Center for Neurosciences

Tucson 5318313, Arizona 5551752, 85718

Los Angeles 5368361, California 5332921

Status

Address

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

Los Angeles 5368361, California 5332921, 90095

San Francisco 5391959, California 5332921

Status

Address

University of California, San Francisco Department of Neurological Surgery

San Francisco 5391959, California 5332921, 94143

Aurora 5412347, Colorado 5417618

Status

Address

University of Colorado School of Medicine

Aurora 5412347, Colorado 5417618, 80045

Baycare Medical Group, Tampa 4174757, Florida 4155751

Status

Address

Baycare Medical Group

Tampa 4174757, Florida 4155751, 33607

Emory University Hospital, Atlanta 4180439, Georgia 4197000

Status

Address

Emory University Hospital

Atlanta 4180439, Georgia 4197000, 30322

Beacon Medical Group, Elkhart 4919987, Indiana 4921868

Status

Address

Beacon Medical Group

Elkhart 4919987, Indiana 4921868, 46530

Baptist Health Paducah, Paducah 4048662, Kentucky 6254925

Status

Address

Baptist Health Paducah

Paducah 4048662, Kentucky 6254925, 42003

Oschner Medical Center, New Orleans 4335045, Louisiana 4331987

Status

Address

Oschner Medical Center

New Orleans 4335045, Louisiana 4331987, 70121

Baltimore 4347778, Maryland 4361885

Status

Address

Johns Hopkins University School of Medicine

Baltimore 4347778, Maryland 4361885, 21287

McLaren Bay Neurology Associates, Bay City 4985180, Michigan 5001836

Status

Address

McLaren Bay Neurology Associates

Bay City 4985180, Michigan 5001836, 48707

Henry Ford Health System, Detroit 4990729, Michigan 5001836

Status

Address

Henry Ford Health System

Detroit 4990729, Michigan 5001836, 48202

Depaul Hospital, Bridgeton 4378391, Missouri 4398678

Status

Address

Depaul Hospital

Bridgeton 4378391, Missouri 4398678, 63044

St. Louis University Hospital, St Louis 4407066, Missouri 4398678

Status

Address

St. Louis University Hospital

St Louis 4407066, Missouri 4398678, 63110

Las Vegas 5506956, Nevada 5509151

Status

Address

Western Regional Ctr for Brain and Spine Surgery

Las Vegas 5506956, Nevada 5509151, 89102

Dartmouth-Hitchcock Medical Center, Lebanon 5088597, New Hampshire 5090174

Status

Address

Dartmouth-Hitchcock Medical Center

Lebanon 5088597, New Hampshire 5090174, 03756

Jfk Medical Center, Edison 5097529, New Jersey 5101760

Status

Address

Jfk Medical Center

Edison 5097529, New Jersey 5101760, 08820

Albany Medical Center Hospital, Albany 5106834, New York 5128638

Status

Address

Albany Medical Center Hospital

Albany 5106834, New York 5128638, 12208

Roswell Park Cancer Institute, Buffalo 5110629, New York 5128638

Status

Address

Roswell Park Cancer Institute

Buffalo 5110629, New York 5128638, 14263

Brain Tumor Center, Lake Success 5123853, New York 5128638

Status

Address

Brain Tumor Center

Lake Success 5123853, New York 5128638, 11042

Crouse Neuroscience Institute, Syracuse 5140405, New York 5128638

Status

Address

Crouse Neuroscience Institute

Syracuse 5140405, New York 5128638, 13210

Vidant Medical Center, Greenville 4469160, North Carolina 4482348

Status

Address

Vidant Medical Center

Greenville 4469160, North Carolina 4482348, 27834

Wake Forest Baptist Med Center, Winston-Salem 4499612, North Carolina 4482348

Status

Address

Wake Forest Baptist Med Center

Winston-Salem 4499612, North Carolina 4482348, 27157

Mount Carmel Neurosurgery, Columbus 4509177, Ohio 5165418

Status

Address

Mount Carmel Neurosurgery

Columbus 4509177, Ohio 5165418, 43222

Oklahoma City 4544349, Oklahoma 4544379

Status

Address

University of Oklahoma - Stevenson Cancer Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

University of Pennsylvania Health System, Philadelphia 4560349, Pennsylvania 6254927

Status

Address

University of Pennsylvania Health System

Philadelphia 4560349, Pennsylvania 6254927, 19104

Grand Strand Medical Center, Myrtle Beach 4588718, South Carolina 4597040

Status

Address

Grand Strand Medical Center

Myrtle Beach 4588718, South Carolina 4597040, 39572

Seattle 5809844, Washington 5815135

Status

Address

University of Washington School of Medicine

Seattle 5809844, Washington 5815135, 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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