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Spine - Lumbar
TOPS Artificial Facet System – For patients with low back pain and leg pain from moderate to severe lumbar stenosis accompanied by facet arthrosis and/or degenerative spondylolisthesis.
DIAM™ – Spinal Stabilization System In Patients With Degenerative Lumbar Spinal Stenosis.
REGAIN™ - Artificial Disc for the Treatment of Degenerative Disc Disease
Spine - Cervical
DISCOVER™ /DePuy Spine: 1-Level or 2-level Cervical Artificial Disc Replacement vs fusion: For patients with degenerative disc disease in the cervical spine at 1-level or 2-levels.
Brain
Transmolecular –I-TM-601 – For patients that have a recurrent or progressive high-grade glioma (malignant brain tumor) requiring surgery for the removal of the tumor. This study compares the safety and tolerability of two different doses of TM-601 and to evaluate the effect of this drug on the high-grade gliomas.
SRS + SURGERY – A Prospective Analysis of Neoadjuvant Radiosurgery and Surgical Resection for the Treatment of 1-3 Cerebral Metastases
(CTSU NO574) – For patients that have cancer that has metastasized to the brain.
This trial is A Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in the Management of Patients with One to Three Cerebral Metastases.
Gliasite® Radiation Therapy System (RTS) (Gliasite Registry) For the treatment of Resectable Malignant Brain Tumors.
CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
(Humanitarian Use Device) – for endovascular treatment of wide-neck, intracranial, saccular or fusiform aneurysms.
Boston Scientific Target NEUROFORM™ Microdelivery Stent System (Humanitarian Use Device) – for use in treatment of wide-neck, intracranial aneurysms.
Facility Overview
The Research Department of Carolina Neurosurgery & Spine Associates has a long history of accomplishment in national and international clinical trials. We have worked with multiple pharmaceutical and device companies such as NeoPharm, Guilford, Medtronic, Novo Nordisk, Stryker, Spinal Motion, Proxima Therapeutics, Concetric, FzioMed.
Facility
- Clinical Trial Participation:
- Inpatient
- Outpatient
- Phase I, II, III, IV, V
- Investigator Initiated Protocol
Description:
- _______sq ft facility with 17 Board Certified Neurosurgeons
- Monitor Station
- Local or Central IRB
- -70 & -20 Freezer
- MRI on-site
- Local or Central Lab
- Daily Fedex, UPS pickup
- Affilated with Carolinas Medical Center and Presbyterian hospitals.
- Located 1 Block from Carolinas Medical Center (downtown Charlotte)
- Easy Access to all major interstates
- Bus-station 2 blocks from site
- Generate Site Source Documents
- Generate Informed Consents
Quality Assurance:
- Mentoring program for new employees, Carolinas Medical Center
- GCP Training required for all new employees
- HIPPA Training/Certificate
- Maintain and enforce policies and procedures
- Internal monitoring of CRF, Regulatory
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Our practice newsletter delivers insights into the latest treatment options available in the field of neurosurgery. Read our latest issue |
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The spine surgeons of our practice perform minimally invasive spine procedures, and are currently involved in groundbreaking clinical trials. Learn more |
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As the primary provider of brain tumor services in the Charlotte region, our practice coordinates state-of-the-art treatment and patient support. Learn more |
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The Merci® Retriever is an innovative device that actually removes blood clots from the brain of patients experiencing ischemic stroke.
Learn more |
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