Clinical trials: Cerebrospinal Fluid Leak
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
Dural Tear, Cerebrospinal Fluid Leak
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.
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery.
- Trial name
- NEOART (NCT04145544)
- Testing
- Implantation of the ArtiFascia®, Implantation of other commercial suturable dural substitute
- Where
- 9 sites in Belgium, Czechia and 3 more
- Volunteers
- 92 people
- Sponsor
- Nurami Medical Ltd
Subjects Scheduled for Supra-/Infratentorial Craniotomy
Efficacy of Tachosil as Dural Sealant Compared to Standard Treatment
Main objective of this trial is to assess the hypothesis whether the application of TachoSil® as a dural sealant improves the quality of craniotomy procedure and outcome in general compared with standard dural closure techniques…
- Trial name
- NCT00999999
- Testing
- Craniotomy supra- or infratentorial, dural closure
- Where
- Switzerland
- Volunteers
- 241 people
- Sponsor
- University Hospital, Basel, Switzerland
Spinal Anesthesia, Intracranial Pressure Change
Effect of Spinal Needle Type on Optic Nerve Sheath Diameter
The optic nerve sheath is a continuation of the dura mater, extending along the subarachnoid space surrounding the optic nerve. Consequently, changes in intracranial pressure cause an augmentation or contraction in the diameter…
- Conditions
- Spinal Anesthesia, Intracranial Pressure Change, Optic Nerve Sheath Diameter, Orthopedic Surgery
- Trial name
- NCT06497634
- Testing
- 25 PP, 25 Q, 27 Q
- Where
- Turkey (Türkiye)
- Volunteers
- 165 people
- Sponsor
- Bagcilar Training and Research Hospital
Heart Arrest, Out-Of-Hospital, Brain Swelling
The Effect of Lumbar CSF Drainage on the Neurologic Outcome Improvement in OHCA Underwent TTM
Aim: The investigators aim to evaluate the effect of lumbar cerebrospinal fluid (CSF) drainage on neurologic outcome in post-cardiac arrest (CA) patients treated with target temperature management (TTM).
- Trial name
- NCT04328974
- Testing
- lumbar CSF drainage
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Chungnam National University Hospital
Chronic Subdural Hematoma
Spinal CSF Leaks in Chronic Subdural Hematoma
Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000.
- Trial name
- SPICE (NCT06323434)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- University of Freiburg
Head Injury, Subarachnoid Hemorrhage
Influence of Drainage on EVD ICP-signal
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer.
- Trial name
- NCT03164434
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Subarachnoid Hemorrhage
Lumbar Drainage in Subarachnoid Haemorrhage
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years).
- Trial name
- LUMAS (NCT00842049)
- Testing
- Lumbar Drain (Medtronic lumbar drainage system), No lumbar drain
- Where
- United Kingdom
- Volunteers
- 210 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Dura Defects
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
- Trial name
- NCT01174992
- Testing
- Evicel, Sutures only
- Where
- 12 sites in Belgium, Finland and 4 more
- Volunteers
- 139 people
- Sponsor
- Ethicon, Inc.
Cerebrospinal Fluid Leak
The EVICEL® Neurosurgery Phase III Study
The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
- Trial name
- NCT02457546
- Testing
- EVICEL Fibrin Sealant, Hydrogel sealant
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 234 people
- Sponsor
- Ethicon, Inc.
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
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.
CSF Leakage
Endoscopic Repair of Frontal Sinus CSF Leak
This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years.
- Trial name
- NCT05024643
- Testing
- Endonasal endoscopy
- Volunteers
- 27 people
- Sponsor
- Al-Azhar University
CSF Leak, Fistula
Value of Radionuclide Cisternography
Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA).
- Trial name
- VERTICAL (NCT02876614)
- Volunteers
- 113 people
- Sponsor
- Hospices Civils de Lyon
CerebroSpinal Fluid (CSF) Leak
The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Spinal CSF leaks are considered as rare disease. They cause a variety of symptoms, mainly culminating in a chronic headache syndrome. Crucially, yet often disregarded, the disease holds the potential for cure.
- Trial name
- SEAL (NCT06711731)
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- University Hospital Freiburg
Fibrolipoma of Filum Terminale, Lipomyelomeningocele
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF)…
- Conditions
- Fibrolipoma of Filum Terminale, Lipomyelomeningocele, Split Cord Malformation, Dermal Sinus
- Trial name
- NCT01867268
- Testing
- Acetazolamide, prone positioning, Acetazolamide+ prone positioning
- Where
- Iran
- Volunteers
- 144 people
- Sponsor
- Tehran University of Medical Sciences
CSF Leak
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery
This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen.
- Trial name
- NCT04503161
- Testing
- Duragen with Collagen Hydrodel and ASCs
- Volunteers
- healthy volunteers welcome
- Sponsor
- Stanford University
Cerebrospinal Fluid Leak, Dural Tear
Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and…
- Trial name
- NCT07092267
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
- Volunteers
- 20 people
- Sponsor
- Nurami Medical Ltd
Cerebrospinal Fluid Leak
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural…
- Trial name
- NCT03566602
- Testing
- Dura Sealant Patch
- Where
- 3 sites in Netherlands, Switzerland
- Volunteers
- 40 people
- Sponsor
- Polyganics BV
Cerebrospinal Fluid Drainage
Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
- Trial name
- NCT04505423
- Testing
- Blind CSF Drain Placement, Fluoroscopy-guided Drain Placement
- Where
- United States
- Volunteers
- 302 people
- Sponsor
- University of North Carolina, Chapel Hill