Clinical Trials

CREST-2: Carotid Revascularization and Medical Management for Carotid Stenosis
The purpose of CREST-2 is to compare three different methods of stroke prevention to find the safest and most effective treatment. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery in your neck (called revascularization) for treatment of plaque buildup. The two procedures available in this trial are carotid endarterectomy and carotid stenting. All study participants will receive intensive medical management to help control their risk factors for stroke.

Principal investigator: Andrew Ringer, MD
Trial Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
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GammaTile vs. Stereotactic Radiotherapy for Newly-Diagnosed Metastatic Brain Tumors

The purpose of this study is to compare the safety and effectiveness of surgical tumor removal followed by stereotactic radiotherapy (SRT) to surgical tumor removal in conjunction with intraoperative radiation therapy using GammaTiles. A GammaTile is a collagen sponge containing four radiation seeds. After tumor removal, the tiles are placed in the tumor bed to deliver radiation to any remaining cells. Patients will be randomized to receive either intraoperative GammaTile radiotherapy or traditional radiotherapy 3-4 weeks after tumor removal (standard of care).

Principal investigators: Vince DiNapoli, MD, PhD
Trial Sponsor: GT Medical Technologies, RoadsStudy.com
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M6-C Artificial Cervical Disc vs. ACDF at Two-Levels IDE Study

This study compares a novel artificial cervical disc device, called Spinal Kinetics M6-C, to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression. This study aims to understand if the M6-C artificial disc is better, worse, or the same as ACDF for pain relief and long-term outcomes. The unique design of M6-C has a compressible viscoelastic nuclear core and an annular structure. Artificial disc surgery preserves motion of the neck, whereas fusion stops motion.

Principal investigator: Bryan Krueger, MD
Trial Sponsor: Orthofix
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Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

The purpose of this observational registry study is to evaluate real-world clinical outcomes and patient-reported outcomes that measure the effectiveness and safety of STaRT. Patients (N=600) with surgically resected brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation-associated adverse events.

Principal investigator: Vince DiNapoli, MD, PhD
Trial Sponsor: GT Medical Technologies
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'Smart Socks' measure gait and balance to quantify functional improvement with spinal cord simulation (SCS)
The purpose of this prospective study is to quantify measures of gait movement and balance before and during the trial stimulation, and after permanent implantation. Assessment of gait and balance parameters in candidates that receive spinal SCS are recorded using pressure sensitive, sensor-implanted socks (Palarum PUP® Smart Socks, Cincinnati, OH). Four evaluations will be performed: 1) baseline before trial implant, 2) with SCS trial implant, 3) 3 months after permanent implant, and 4) 1 year follow-up interview. Quantifying measures of gait balance may help to inform the long term success of SCS placement for back pain. 

Investigators: George Mandybur, MD, Luke Iding, DPT, Marc Orlando, MD
Trial Sponsor: MERF and Palarum
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Spinal Cord Stimulation for treatment of neuropathic pain and symptoms related to restless legs syndrome (RLS)
The purpose of this study is to evaluate patients who are scheduled to receive Spinal Cord Stimulation (SCS) for back pain, and additionally have moderate to severe Restless Legs Syndrome, to understand the amount of RLS symptom alleviation as a result of spinal cord stimulation. Spinal cord stimulation is a well-established technique for the management of chronic neuropathic pain. Patients scheduled to undergo implantation of a spinal cord stimulator for chronic low back pain that have a diagnosis of moderate to severe RLS and qualify for the study will be invited to participate.

Principal Investigator: Marc Orlando, MD
Sponsor: Nevro, Inc.
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Transforaminal Lumbar Interbody Fusion (TLIF) using Infuse™ Bone Graft and the Capstone™ Spinal System for degenerative spine disease
The purpose of this study is to evaluate the Infuse™ Bone Graft in combination with the Capstone™ Spinal System and an implantable, metal rod and screw system and autograft bone (your own bone) to see if it is safe and effective when used in a TLIF surgery. Two different amounts of the Infuse™ Bone Graft material will be tested. The Infuse™ Bone Graft is considered investigational because it has not been approved by the U.S. Food and Drug Administration (FDA) for use in a TLIF surgery. The Infuse™ Bone Graft is approved by the FDA for use in another type of spinal fusion surgery using other spinal fusion devices. Participation in the study will last between 2 and 4 years.

Principal Investigator: Robert Bohinski, MD, PhD
Sponsor: Medtronic
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Closed trials or in follow-up

  • Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
  • INTREPID Study for Deep Brain Stimulation
  • SURPASS Study: HF10 Therapy using Surgical Leads
  • Minimally Invasive Surgery + rt-PA for ICH Evacuation (MISTIE III)
  • RENEW Study: HF10 Therapy in Patients who Previously Failed Traditional Spinal Cord Stimulation
  • The EVICEL® Neurosurgery Phase III Study
  • Cancer Genome Atlas Patient Enrollment and Specimen Qualification Criteria Grade II-IV Gliomas
  • Rindopepimut/GM-CSF with Temozolomide for EGFRvIII-positive Glioblastoma
  • Dasatinib or Placebo Combined with Chemoradiotherapy for Glioblastoma
  • First-in-Human Study Evaluating AMG 595 in Subjects with Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III
  • EDGE-NEWTON: Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage
  • Condition of Approval Study for the Treatment of Lumbar Spinal Stenosis with X-STOP® PEEK IPD® in Moderately Symptomatic Patients
  • Deep Brain Stimulation (DBS) Long Term Follow-Up
  • CLEAR III (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage) Phase III
  • The Injury and Traumatic Stress (INTRuST) Consortium Neuroimagin Acquisition and Archival
  • The Injury and Traumatic Stress (INTRuST) Consortium Biorepository
  • Acoustic Neuromas: Subtotal Resection & Radiosurgery
  • Chiari Malformation Study
  • RAMP: Prospective, Randomized, Multicenter Clinical Study Comparing Axial Lumbar Interbody Fusion (AxiaLIF®) and Transforaminal Lumbar Interbody Fusion (TLIF) Spinal Procedures
  • Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (BOOST II)
  • Spreading Depression in Brain Trauma (COSBID-TBI)
  • CREATE – Cognitive Remediation after Traumatic Exposure Trial
  • Adherus™ Dural Sealant in Cranial Procedures
  • Monitoring of Delayed Ischemia after Subarachnoid Hemorrhage
  • ICH Removal: Minimally Invasive Surgery + rt-PA (MISTIE)
  • Stenting versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
  • Angio-Seal™ Vascular Closure Device Following Interventional Radiology Procedures
  • PRET: Patients Prone to Recurrence after Endovascular Treatment
  • Target Imaging for Assistance in Treatment of Parkinson's
  • SLV334 in Traumatic Brain Injury
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-3)
  • Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
  • Carotid Occlusion Surgery Study (COSS)
  • Clazosentan in Aneurysmal Subarachnoid Hemorrhage
  • INFUSE® Bone Graft for Spine Fusion
  • Libra™ Deep Brain Stimulator for Parkinson's Disease
  • Duragen Plus to Minimize Adhesions after Lumbar Discectomy
  • Gliadel Wafers & Permanent I-125 Seeds for Glioblastoma
  • Biomarkers for Subarachnoid Induced Cerebral Vasospasm
  • IVH Removal: Intraventricular rt-PA
  • Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
  • Comparison of Dura Sealants for Cranial Surgery
  • New Spinal Sealant for Dura Repair
  • Eon™ Spinal Cord Stimulator for Chronic Back & Leg Pain
  • Prevention of Disability after Spinal Cord Injury (Cethrin)
  • Prevention of Seizures after Brain Injury
  • Near-infrared Spectroscopy to Detect Bleeding in the Brain
  • Brain Stimulation for Arm/Hand Weakness After a Stroke
  • Assessment of Surgery for Cervical Spondylotic Myelopathy
  • Lumbar Stabilization using the AxiaLif system
  • Evaluation of the PathFinder™ System for Pedicle Screw Insertion
  • Evaluation of the CODA Expandable Fusion Cage
  • FlexiCore™ Artificial Disc for the Treatment of Discogenic Pain
  • ChillerStrip™ Hypothermia System for Aneurysm Surgery
  • Safety and Tolerability of DTI-015 in Patients with Recurrent GBM
  • Hemicraniectomy and Durotomy Upon Deterioration from Infarction Related Swelling (HeADDFIRST)
  • Evaluation of ForSite Device to Measure Pupillary Size
  • National Acute Brain Injury Study: Hypothermia II
  • Prevention of Vasospasm & New Infarction after Aneurysmal SAH Following Administration of Clazosentan
  • Evaluation of a Single IV Dose of Dexanabinol in Patients Suffering from Severe TBI
  • Procrit® (Epoetin Alfa) Administered Perioperatively Versus Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery
  • DuraSeal™ System as an Adjunct to Sutured Dural Repair During Cranial Surgery

Humanitarian Use Devices

Wingspan™ Stent for Blocked Brain Arteries
The purpose of this study is to monitor the effectiveness of the Wingspan Stent System to open arteries in the brain that have become blocked by a clot or narrowed by plaque.

Principal investigator: Andrew Ringer, MD

Neuroform™ Stent for Wide-neck Aneurysms
The purpose of this study is to monitor the effectiveness of the Neuroform Stent in treating wide-neck aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

Onyx Liquid Embolic System HD-500
The purpose of this study is to monitor the effectiveness of the Onyx Liquid Embolic System in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD

CORDIS ENTERPRISE™ Vascular Reconstruction Device & Delivery System
The purpose of this study is to monitor the effectiveness of the Cordis Enterprise Device in treating aneurysms in the brain.

Principal investigator: Andrew Ringer, MD



Clinical Trials

 

For enrollment information please contact us:


ClinicalTrials@mayfieldclinic.com

 

For patients:
Understanding clinical trials