Clinical trials: Cerebrospinal Fluid
CerebroSpinal Fluid (CSF) Leak, Dural Tear
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine…
- Trial name
- NEOFIX (NCT07765862)
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries., Standard of Care (Investigator Choice)
- Volunteers
- 228 people
- Sponsor
- Nurami Medical Ltd
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial
Cerebrospinal Fluid Leak, Dural Tear
Acetazolamide to Reduce Spinal Fluid Leaks After Spine Surgery.
This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery.
- Conditions
- Cerebrospinal Fluid Leak, Dural Tear, Incidental Durotomy
- Trial name
- NCT07876713
- Testing
- Acetazolamide, Standard Care (in control arm)
- Where
- Egypt
- Volunteers
- 26 people
- Sponsor
- Ain Shams University
Postdural Puncture Headache, Cerebrospinal Fluid Leak
Sphenopalatine Ganglion Nerve Block for Postdural Puncture Headache in Obstetrics
The SNOB study is a prospective, randomized, double-blind, placebo-controlled, cross-over pragmatic trial that has been designed in accordance with the CONSORT guidelines.
- Conditions
- Postdural Puncture Headache, Cerebrospinal Fluid Leak, Spinal; Puncture, Complications, Headache
- Trial name
- SNoB (NCT03181464)
- Testing
- Lidocaine 4%
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Hadassah Medical Organization
Type I Chiari Malformation, Cerebral Hemodynamic
Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations
A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations.
- Conditions
- Type I Chiari Malformation, Cerebral Hemodynamic, Craniospinal Hydrodynamic, Phase Contrast MRI
- Trial name
- NEUROFLUX-C (NCT06502431)
- Testing
- phase contrast sequences
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Skull Base Neoplasms, Cerebrospinal Fluid Leakage
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic…
- Conditions
- Skull Base Neoplasms, Cerebrospinal Fluid Leakage, Nasal; Hypertrophy, Mucous Membrane (Septum)
- Trial name
- NCT05898074
- Testing
- Non-Absorbable Packing (Silastic Splint), PuraGel (RADA16) Hydrogel
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Indiana University
Cerebrospinal Fluid Leak
A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of an absorbable medical adhesive (developed by Guangzhou Maipu Regenerative…
- Trial name
- NCT07768553
- Testing
- Absorbable Medical Adhesive, TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)
- Where
- 9 sites in China
- Volunteers
- 132 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Spinal Dural Defect, Cerebrospinal Fluid Leakage
Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
- Conditions
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- Trial name
- NCT07754344
- Testing
- Dural medical adhesive, Standard dural reinforcement surgery
- Where
- 6 sites in China
- Volunteers
- 141 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Osteopathic Manipulative Treatment (OMT) Effects on Cerebrospinal Fluid (CSF) Dynamics
Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
his study aims to investigate whether Osteopathic Manipulative Treatment (OMT) affects cerebrospinal fluid (CSF) flow and glymphatic clearance in the human brain.
- Trial name
- NCT07629765
- Testing
- Osteopathic Manipulative Treatment (OMT)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Edward Via Virginia College of Osteopathic Medicine
CSF Leak, CSF Pressure Increased
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
Dear Sir or Madam, You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative…
- Conditions
- CSF Leak, CSF Pressure Increased, CSF Circulation Disorder, Puncture
- Trial name
- PSEUDO (NCT07614399)
- Testing
- Lumbar Drainage, Pseudomeningocele Puncture, Puncture with Fibrin Glue Application
- Where
- Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Charles University, Czech Republic
CSF Leak
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
- Trial name
- CSF (NCT07368348)
- Testing
- Internal Nasal Splint-Supported Free Graft, Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Kafrelsheikh University
Brain Tumor Adult, Brain Tumor Benign
Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor.
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy
- Trial name
- CSF-IMR (NCT07411690)
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- Medical University of Warsaw
Hydrocephalus, Ventriculoperitoneal Shunt Infection
Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Objectives Primary: To measure the reduction in VP shunt infection rates using topical vancomycin powder. Secondary: To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).
- Conditions
- Hydrocephalus, Ventriculoperitoneal Shunt Infection, Surgical Site Infection (SSI), Cerebrospinal Fluid Shunt Infection
- Trial name
- NCT07547826
- Testing
- Topical Vancomycin Powder, Standard Perioperative Care
- Where
- Egypt
- Volunteers
- 164 people
- Sponsor
- Assiut University
Normal Pressure Hydrocephalus, Sleep Apnea
Normal Pressure Hydrocephalus and Sleep Apnea
Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells.
- Conditions
- Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
- Trial name
- NPH/OSA (NCT04471740)
- Testing
- CSF shunt diversion
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- University of Valencia
Sellar Tumor, Endonasal Surgery
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month…
- Conditions
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- Trial name
- EEEA-AMSBP (NCT07539792)
- Testing
- Absorbable and moldable skull base support plate
- Where
- 8 sites in China
- Volunteers
- 126 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Skull Base
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
This study is a randomized controlled trial conducted across multiple centers. Due to the anatomical and pathological complexity of endoscopic endonasal skull base surgery, the study scope was restricted to the midline anterior…
- Trial name
- BRO (NCT07465861)
- Testing
- non-bed-rest, 2-day bed-rest, 1-day bed-rest
- Volunteers
- 316 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Cardiac Arrest (CA), Cerebrospinal Fluid
Molecular Insights Into Post-Cardiac Arrest Brain Injury Via CSF Multi-Omics
The goal of this study is to uncover the molecular mechanisms responsible for secondary brain injury in patients with post-cardiac arrest syndrome by analyzing cerebrospinal fluid (CSF) using multi-omics techniques.
- Conditions
- Cardiac Arrest (CA), Cerebrospinal Fluid, Multiomics, Hypoxic-Ischemic Brain Injury
- Trial name
- PCABI-OMICS (NCT07481396)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Chungnam National University Hospital
Leak, Cerebrospinal Fluid
CraniSeal Post Approval Study
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct…
- Trial name
- NCT06406790
- Testing
- CraniSeal, DuraSeal
- Where
- 8 sites in United States
- Volunteers
- 224 people
- Sponsor
- Pramand LLC
Pseudotumor Cerebri, Cerebrospinal Fluid
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses…
- Conditions
- Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
- Trial name
- HYDROPTIC (NCT05050864)
- Testing
- venous sinus stenting, Neurosurgical internal ventricular shunt
- Where
- France
- Volunteers
- 276 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild