Clinical trials: Intracranial Surgery
Brain Tumor, Recurrent, Brain Tumor
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
- Conditions
- Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic
- Trial name
- NCT04427384
- Testing
- GammaTile
- Where
- 54 sites in United States
- Volunteers
- 600 people
- Sponsor
- GT Medical Technologies, Inc.
Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation
Postmarket Study of Tarvos Microguidewire in Neurovascular Interventional Surgery
This investigation is to evaluate the clinical effectiveness and safety of the Tarvos Microguidewire in the neurovascular interventional surgery.
- Conditions
- Intracranial Aneurysm, AVM - Cerebral Arteriovenous Malformation, AV Fistula, Acute Ischemic Stroke
- Trial name
- NCT07500155
- Testing
- Tarvos Microguidewire
- Where
- China
- Volunteers
- 121 people
- Sponsor
- Keuro MedTech
Intracerebral Hemorrhage, Brain Hemorrhage
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular…
- Conditions
- Intracerebral Hemorrhage, Brain Hemorrhage, Intraventricular Hemorrhage
- Trial name
- PRONTO (NCT04178746)
- Testing
- Artemis Neuro Evacuation Device
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Penumbra Inc.
Carotid Artery Diseases, Stroke
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be…
- Conditions
- Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis
- Trial name
- BEACH (NCT00316108)
- Testing
- WALLSTENT® Endoprosthesis™
- Where
- 50 sites in United States
- Volunteers
- 747 people
- Sponsor
- Boston Scientific Corporation
Aneurysmal Subarachnoid Hemorrhage
Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space…
- Trial name
- REVERSE (NCT02560532)
- Testing
- Clazosentan
- Where
- 11 sites in Finland, France and 1 more
- Volunteers
- 25 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Intracranial Surgery, Extracranial Surgery
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vital™ System and accessories when used as intended in a real-world setting.
- Conditions
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery, Extratemporal Surgery
- Trial name
- PSR-ENT (NCT06637995)
- Testing
- Intraoperative Nerve Monitoring
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Medtronic
Intracerebral Hemorrhage, Cerebral Hemorrhage
MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage
The primary objective of this trial is to provide preliminary safety data of minimally invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral hemorrhage (ICH).
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracranial Hemorrhage, Basal Ganglia Hemorrhage
- Trial name
- NCT04839770
- Testing
- Axonpen system
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- Clearmind Biomedical Inc.
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Intracranial Aneurysm
Axium Coil in Completing Endovascular Aneurysm Surgery Study
The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.
- Trial name
- ACCESS (NCT01194388)
- Testing
- MicroFx™ PGLA COILS
- Where
- United States
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Aneurysmal Subarachnoid Hemorrhage
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm…
- Trial name
- CONSCIOUS-2 (NCT00558311)
- Testing
- Clazosentan
- Where
- 117 sites in United States, Australia and 27 more
- Volunteers
- 1,157 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Cranial Aneurysm
Navigation Support With Mixed Reality With CORTEXPLORER MED
During the last 15 years, neuronavigation has become an essential neurosurgical tool for pursuing minimal invasiveness and safety.
- Trial name
- CXmed (NCT05269498)
- Testing
- CORTEXPLORER MED
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- cortEXplore GmbH
Postoperative Complications, Memory Disorders
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic…
- Trial name
- NCT00736125
- Testing
- pulsatile saline lavage, carbon dioxide lavage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Kinamed Incorporated
Aneurysmal Subarachnoid Hemorrhage
Clazosentan in Aneurysmal Subarachnoid Hemorrhage
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of…
- Trial name
- CONSCIOUS-3 (NCT00940095)
- Testing
- Clazosentan 5 m/h, Clazosentan 15 mg/h
- Where
- 145 sites in United States, Argentina and 26 more
- Volunteers
- 577 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Intracerebral Hemorrhage, Cerebral Hemorrhage
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute…
- Conditions
- Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage
- Trial name
- ENRICH (NCT02880878)
- Testing
- Early Surgical Hematoma Evacuation
- Where
- 36 sites in United States
- Volunteers
- 300 people
- Sponsor
- Nico Corporation