Clinical Trials

Our Mission Includes Research

Mayfield has a long history of innovation and clinical research through the Mayfield Education and Research Foundation. Mayfield is a member of the the American Spine Registry that collect and share outcomes data to improve quality of care for all patients. We collaborate with industry to improve and test new surgical technologies and devices. We offer patients opportunity to participate in cutting-edge clinical trials. Learn more about current active trials for your diagnosis below:

Decreasing adjacent segment disease by strengthening the lumbar multifidus muscles
This study seeks to understand the role the multifidus muscle plays in recovery and prevention of adjacent level disease after lumbar fusion surgery. Using ultrasound, the multifidus muscles will be measured before and after a 1-2 level fusion between L3-S1 of the spine. All participants will follow a spinal stabilization and strengthening protocol. Five evaluations will be performed: baseline before surgery, 3-, 6-, 9-weeks after surgery, and 1 year follow-up interview.

Principal investigator: Robert Bohinski, MD, Megan Connett, DPT
Trial Sponsor: Mayfield Physical Therapy


Brain Slice Explants to Predict Drug Response in Brain Tumors
This is a biospecimen collection study to evaluate the feasibility of engrafting and testing resected brain tumor tissue ex vivo to estimate drug response. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient.

Principal investigator: Yair Gozal, MD, PhD, Vince DiNapoli, MD, PhD
Trial Sponsor: UNC Lineberger Comprehensive Cancer Center

More info: ClinicalTrials.gov


Complex Aneurysm Registry (CAR)

This is an observational registry study that will collect data on patients undergoing endovascular treatment for intracranial aneurysms with MicroVention devices. Patients will receive standard of care treatment as determined by their treating physician. Data will be collected from medical records and follow-up visits, including functional assessments, imaging, and safety information.

Principal investigator: Andrew Ringer, MD
Trial Sponsor: Microvention
More info: Clinicaltrials.gov


CHESS: Chronic Subdural Hematoma Treatment with Embolization versus Surgery Study

The purpose of the CHESS trial is to evaluate the safety and efficacy of Middle Meningeal Artery Embolization (MMAE) against conventional surgery for patients with moderately symptomatic chronic subdural hematoma (cSDH).

Principal investigator: Andrew Ringer, MD
Trial Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

More info: ClinicalTrials.gov


Chiari Surgical Success Scale trial
The Chiari Surgical Success Scale is a prospective multi-center patient registry that will combine patient data from all over the world to understand better how to treat and improve outcomes for patients suffering from Chiari type 1 malformation.

Principal investigator: Yair Gozal, MD, PhD
Trial Sponsor: Chiari Clinical Research Consortium

More info >


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)
More info


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
More info


Closed trials or in follow-up

  • 'Smart Socks' measure gait and balance to quantify functional improvement with spinal cord simulation (SCS)
  • GammaTile vs. Stereotactic Radiotherapy for Newly-Diagnosed Metastatic Brain Tumors
  • Transforaminal Lumbar Interbody Fusion (TLIF) using Infuse™ Bone Graft and the Capstone™ Spinal System for degenerative spine disease
  • Spinal Cord Stimulation for treatment of neuropathic pain and symptoms related to restless legs syndrome (RLS)
  • M6-C Artificial Cervical Disc vs. ACDF at Two-Levels IDE Study
  • 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