Clinical trials: Neurosurgery
Surgery
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
- Trial name
- Annexa-S (NCT04233073)
- Testing
- andexanet alfa
- Where
- 56 sites in United States, Austria and 4 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue…
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Trial name
- IMED-MYVEO (NCT07164053)
- Testing
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 32 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Malignant Glioma, Glioblastoma Multiforme
Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell…
- Conditions
- Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma
- Trial name
- NCT00024557
- Testing
- IL13-PE38QQR, targeted fusion protein therapy, surgery
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- INSYS Therapeutics Inc
Glioblastoma, Brain Tumors
Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
This clinical trial aims to evaluate the feasibility and safety of early post-operative brain PET-MRI imaging in adult patients who have undergone surgery for suspected glioblastoma.
- Conditions
- Glioblastoma, Brain Tumors, Brain Imaging
- Trial name
- EARLYBRAINPET (NCT07274397)
- Testing
- Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Beta Emitting Accurate Monitored Systems
Neurosurgery, Surgical Planning
Real Time Craniotomy Planning Using Mixed Reality
This study is a prospective observational study designed to evaluate the effectiveness of Brainlab's Mixed Reality Viewer in enhancing the accuracy and efficiency of preoperative craniotomy planning.
- Conditions
- Neurosurgery, Surgical Planning, Brain Tumor Adult, Craniotomy Tumor Removal Surgery
- Trial name
- NCT07468370
- Testing
- Mixed Reality Glasses/Viewer, Survey using a questionnaire.
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Brainlab AG
Malignant Glioma, Glioblastoma Multiforme
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell…
- Conditions
- Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma
- Trial name
- NCT00024570
- Testing
- IL13-PE38QQR, targeted fusion protein therapy, surgery
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- INSYS Therapeutics Inc
Spinal Cord Injury
Cethrin in Acute Cervical Spinal Cord Injury
This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury.
- Trial name
- NCT02053883
- Testing
- Cethrin (BA-210)
- Sponsor
- BioAxone BioSciences, Inc.
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
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
Pressure Ulcer
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting.
- Trial name
- NCT02565797
- Testing
- DabirAIR alternating pressure overlay
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Dabir Surfaces Inc
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.
Primary Brain Tumor
Laser Ablation in Stereotactic Neurosurgery (LAISE): NeuroBlate® Retrospective Registry
The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions.
- Trial name
- NCT02389855
- Testing
- NeuroBlate® System Therapy
- Where
- 9 sites in United States
- Volunteers
- 144 people
- Sponsor
- Monteris Medical