N/A N=105 Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Cranial Dura Repair
Primary: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele — 57; 33 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=250 Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Elective Cranial Procedures With Dural Incision
Primary: Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak /…
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=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=92 A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Dural Tear · Cerebrospinal Fluid Leak
Primary: Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. — 0; 0; 27; 58…
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…
Phase 3 N=34 Duragen Versus Duraguard in Chiari Surgery
Chiari Malformation
Primary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
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=237 DuraSeal Sealant Post Market Study
Elective Cranial Procedures With Dural Incision
Primary: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to…
N/A N=376 Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Chronic Subdural Hematoma
Primary: Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any…
N/A N=37 Ventriculostomies in SAH: ICP Open or Not?
Subarachnoid Hemorrhage
Primary: Cerebral Artery Vasospasm — 16; 7 Participants
N/A N=98 Study to Evaluate Safety & Effectiveness of Spinal Sealant
Cerebrospinal Fluid Leakage, Subdural
Primary: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) — 98.0; 79.2 percentage of participants
N/A N=200 Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Stenoses, Carotid Artery
Primary: Overall Perioperative Complications Between Selective vs. Routine Shunting. — 7; 8 Participants — p=<0.05
N/A N=158 Study to Evaluate Safety and Effectiveness of Spinal Sealant
Spinal Procedure Requiring Dura Incision
Primary: Watertight Dural Closure — 102; 36 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…
N/A N=35 DBS Under General Anesthesia: Comparison To The Standard Technique
Parkinson's Disease
Primary: "Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS) — 48.4; 28.9; 23.52; 22.56 units on a scale — p=<0.001
Phase 3 N=726 TASALL - TachoSil® Against Liquor Leak
Cerebrospinal Fluid Leaks
Primary: Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure — 6.9…
N/A N=494 Postoperative Headache in Elective Surgery Patients
Drug Withdrawal Headache
Primary: Frequency of Postoperative Headache in Elective Surgery Patients — 126; 37; 89 participants
N/A N=52 Surgical Indirect Revascularization For Symptomatic Intracranial Arterial Stenosis
Intracranial Arterial Stenosis · Intracranial Atherosclerosis · Ischemic Stroke
Primary: Stroke or Death in the Territory of Qualifying Artery — 5 Participants — p=0.08
N/A N=33 Intraoperative Bleeding During Endoscopic Sinus Surgery
Blood Loss
Primary: Estimated Blood Loss — 78.5; 80.3 mL/h — p=0.937
Phase 2 N=18 The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial
Spinal Ischemia · Stroke · Neuroprotection
Primary: Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor…
N/A N=38 INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
Intracranial Hemorrhage
Primary: Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 — 17; 20 Participants
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
N/A N=40 Surgical Theater's Surgery Rehearsal Platform
Cerebral Aneurysm Unruptured · Cerebral Aneurysm Ruptured
Primary: Aneurysm Clip Time
N/A N=5 ICG Use in Angiography for Nasoseptal Flap Harvest
Skull Base Neoplasms
Primary: Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery. — 5 Participants
N/A N=100 In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
Chronic Sinusitis
Primary: Patency Rate — 38; 33 sinus sides — p=0.0391
Phase 4 N=72 Total Intravenous Anesthesia in Sinus Surgery
Advanced Chronic Rhinosinusitis
Primary: Intraoperative Visual Field Assessment — 3.3; 4.3; 3.3; 4.2 units on a scale
N/A N=69 Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis
Parkinson's Disease
Primary: Change in Motor OFF Ldopa UPDRS — 14.8 motor UPDRS
Phase 2 N=20 "Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
Migraine Disorders · Chronic Disease
Primary: Number of Adverse Events — 1 Participants
N/A N=203 Optimization and Refinement of Technique in In-Office Sinus Dilation 2
Sinusitis
Primary: Mean Intra-patient Change in SNOT-20 Score — -1.16 Scores on a scale