Phase 4 N=100 Intravenous Acetaminophen in Craniotomy
Postoperative Pain
Primary: Post-Operative Opioid Requirement — 11.0; 10.1 Morphine Equivalents
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=60 Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy
Brain Neoplasms · Surgery · Hyperemia
Primary: Mean Blood Flow Velocity in Middle Cerebral Artery — 63.7; 61.8 cm/s — p=0.554
N/A N=12 MRI for Non-invasive Evaluation of Brain Stress
Craniosynostosis
Primary: Blood Flow and Perfusion — 26.8 ml/min/100g — p=0.004
Phase 1 N=40 Feasibility of Aromatherapy in an Awake Craniotomy Environment
Intracranial Pathology
Primary: Number of Consented Patients — 40 Participants
N/A N=37 Ventriculostomies in SAH: ICP Open or Not?
Subarachnoid Hemorrhage
Primary: Cerebral Artery Vasospasm — 16; 7 Participants
N/A N=162 Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation
Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
N/A N=23 Cranial Cup Use for Correction of Head Shape Deformities
Dolichocephaly
Primary: Feasibility and Safety — 7; 1 count
Phase 3 N=80 Magnesium and Intraoperative Blood Loss in Meningioma Surgery
Meningioma
Primary: Intraoperative Blood Loss — 510; 500 ml — p=0.315
N/A N=3 Advanced Visuohaptic Surgical Planning for Trauma Surgery
Maxillofacial Injuries
Primary: Percentage of Deviation From Actual Surgical Outcome During Virtual Repair of Mandibular Fractures, Using the Novel Visuohaptic Computational Platform That Was Developed…
N/A N=58 Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Glioma
Primary: Extent of Resection — 24; 25 participants
N/A N=190 Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Arthrodesis
Primary: Number of Participants With Bone Fusion — 43; 60 Participants
Phase 2 N=110 Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Intracerebral Hemorrhage
Primary: Safety Outcome Number 1: Rate of Mortality — 9.5; 14.8; 7.1 percentage of participants — p=0.324
N/A N=96 Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Nonsynostotic Plagiocephaly
Primary: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months — 23; 3; 25; 45 Participants — p=0.01
N/A N=236 MIND: Artemis in the Removal of Intracerebral Hemorrhage
Cerebral Hemorrhage · Brain Hemorrhage · Cerebral Parenchymal Hemorrhage
Primary: Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS) — 32; 20; 4; 2 Participants
N/A N=10 Brain Characteristics Noted Prior to and Following Treatment
Nonsynostotic Plagiocephaly
Primary: Number of Participants With Qualitatively Determined Normalization of White Matter Pathways — 2 Participants
N/A N=25 PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Skull Fractures
Primary: Planarity of Bone Flap After Implantation — 23; 0; 2; 17 Participants
N/A N=11 Analyzing Preoperative Stereotactic Radiosurgery With Gamma Knife Icon for Brain Metastases
Brain Metastases
Primary: The Number of Subjects Undergoing Resection Following SRS. — 11 Participants
N/A N=460 Cerebral Autoregulation Monitoring During Cardiac Surgery
Thoracic Surgery · Cardiopulmonary Bypass
Primary: Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. — 79…
Phase 1 N=3 Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
Brain Neoplasms, Primary Malignant
Primary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Phase 4 N=256 Phase IV Bioseal Study in Brain Tumor Surgery
Hemostasis · Meningioma Surgery
Primary: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. — 99.2; 100 % of…
Phase 3 N=499 Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
Intracerebral Hemorrhage
Primary: Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted) — 110; 100; 139; 140 Participants — p=0.73
Phase 3 N=224 Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Cerebrospinal Fluid Leak
Primary: Number of Participants With No CSF Leak During and After Surgery — 76; 87 Participants
N/A N=18 Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
Plagiocephaly, Nonsynostotic
Primary: Change in Cranial Measurements as Measured by CVA — 11.6; 7.1 mm
N/A N=58 Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
Glioma, Motor Pathway
Primary: Extent of Tumor Resection — 40; 7; 7; 4 participants
N/A N=40 Surgical Theater's Surgery Rehearsal Platform
Cerebral Aneurysm Unruptured · Cerebral Aneurysm Ruptured
Primary: Aneurysm Clip Time
N/A N=24 Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
Malignant Neoplasm Brain
Primary: Local Control Rate (LCR) at 6 Months — 0.817 proportion of patients
N/A N=23 Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery
Skull Base Neoplasms · Skull Neoplasms · Bone Neoplasm
Primary: ICG Fluorescence Ratio — 0.92; 0.82 Ratio
N/A N=68 Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
Intracranial Aneurysm · Brain Edema · Scoliosis
Primary: Number of ICU Stays Greater Than 1.5 Days — 13; 20 Number of ICU Stays greater that 1.5 Day
Phase 3 N=234 The EVICEL® Neurosurgery Phase III Study
Cerebrospinal Fluid Leak
Primary: Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or…
N/A N=9 Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
Concussion Injury of Cerebrum · Cranial Osteopathic Medicine
Primary: Change in Concussive Symptoms on the Post Concussion Symptom Scale — 9 units on a scale