Title: “PulseRider Aneurysm Neck Reconstruction Device (ANRD)”
Study Sponsor: Cerenovus
Principal Investigator: Matthew Lawson, MD
Study Synopsis: The PulseRider is authorized by the Federal Law for use with embolic coils for the treatment of un-ruptured, wide-neck, intracranial aneurysms with neck widths≥ 4 mm or dome to neck ration < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery.
The PulseRider have been approved by the Food and Drug Administration (FDA) with a Humanitarian Use Device (HUD) designation. This designation is recognition that the device has a limited patient population of fewer than 8,000 individuals in the United States per year.
Study Status: Implanting
For more information, contact Lutheria Hollis, CCRC at (850) 201-2350
Title: “Aneurysmal Subarachnoid Hemorrhage Trial Randomizing Heparin: ASTROH”
Study Sponsor: University of Louisville School of Medicine
Principal Investigator: Narlin Beaty, MD
Study Synopsis: To investigate the safety and the clinical effect of a continuous low-dose intravenous unfractionated heparin (LDIVH) infusion for the prevention of aneurysmal subarachnoid hemorrhage (aSAH) induced neurocognitive dysfunction.
The study will randomize patients in a 1:1 open label arm. Study patients randomized to LDIVH arm will receive a continuous low dose infusion of UFH for up to 14 days and the Control group will receive the normal standard of care (SOC) which is 5000 units twice a day.
Study Status: Open for enrollment.
For more information, contact Lutheria Hollis, CCRC, at (850) 201-2350.
Title: “Humanitarian Use Device for wide neck intracranial (brain) saccular/fusiform (like a balloon) aneurysms either ruptured or unruptured.”
Study Sponsor: Johnson & Johnson, Inc.
Principal Investigator: Matthew Lawson, MD
Study Synopsis: The use of the Codman Enterprise Stent under the approval of the Humanitarian Device Exemption (HDE) H060001in treatment of wide neck aneurysms via an endovascular approach.
The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is a new device that has been approved by the Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) for use as an alternative treatment. A HUD device used to diagnose or treat a disease or condition affecting fewer than 4,000 individuals in the United States per year. The probable benefit to health outweighs the risks of injury or illness.
Study Status: Only for patients with wide neck intracranial aneurysm(s), either ruptured or unruptured.
For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.
Title: “Florida Center for Brain Tumor Research”
Study Sponsor: University of Florida
Principal Investigator: Matthew Lawson, MD
Study Synopsis: To find cures and develop treatment modalities for brain tumor through the coordinated effort among the state’s public and private universities, hospitals and biomedical industry.
All patients with brain tumors who sign informed consent to participate are eligible.
Study Status: Open for enrollment.
For more information, contact Lutheria Hollis, CCRC, at (850) 201-2350.
Title: “RELIEF- A Global Registry to Evaluate Long Term Effectiveness of Neurostimulation Therapy for Pain”
Study Sponsor: Boston Scientific
Principal Investigator: Albert Lee, MD
Study Synopsis: To better understand the long term results of chronic pain patients treated with BSC Neurostimulation systems.
Patients who qualify will be asked to completed surveys about their pain and experience with their device system.
Study Status: Open for enrollment.
For more information, contact Lutheria Hollis, CCRC, at (850) 201-2350.
Title: “RELIEF- A Global Registry to Evaluate Long Term Effectiveness of Neurostimulation Therapy for Pain and NAVITAS Sub Study – A study to Characterize the Relationship between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients treated with Boston Scientific Neurostimulation Systems”
Study Sponsor: Boston Scientific
Principal Investigator: Albert Lee, MD
Study Synopsis: To better understand the long term results of chronic pain patients treated with BSC Neurostimulation systems and describe the relationship between certain measurements and clinical outcomes in chronic pain for patients treated with Boston Scientific commercially approved neurostimulation systems.
Patients who qualify will be asked to completed surveys about their pain, they will wear chest and wrist biosensors, collect data on eDiary data application including Pain log and complete Fitness assessments.
Study Status: Open for enrollment.
For more information, contact Lutheria Hollis, CCRC, at (850) 201-2350.
Title: “A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain”
Study Sponsor: Boston Scientific
Principal Investigator: Christopher Rumana, MD
Study Synopsis: To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
This is a prospective, multi-center global registry for all commercially approved Boston Scientific neurostimulation systems. Spinal cord stimulation (SCS) is a treatment option for chronic pain that has generally been reserved for patients who have failed multiple, and sometimes all, conservative chronic pain therapies. Study assessments will be required from patients from the baseline up to 36 months post neurostimulation trial. This trial will have up to 4800 enrolled patients and yield up to 3000 subjects with a permanent implant.
Study Status: Open for enrollment.
For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.
Title: “Wingspan Stent System with Gateway PTA Balloon Catheter”
Study Sponsor: Stryker
Principal Investigator: Matthew Lawson, MD
Study Synopsis: Humanitarian Use Device: For use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy in intracranial vessels with≥ 50% stenosis that are accessible to the system.
The Wingspan Stent System with Gateway PTA Balloon Catheter is a new device that has been approved by the Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) for use as an alternative treatment. A HUD device used to diagnose or treat a disease or condition affecting fewer than 4,000 individuals in the United States per year. The probable benefit to health outweighs the risks of injury or illness.
Study Status: Only for patients with intracranial atherosclerotic disease with more than 50% stenosis.
For more information, contact Lutheria Hollis, CCRC, at (850) 877-5115.