Clinical trials: CSF Leak
Cerebrospinal Fluid Leaks
TASALL - TachoSil® Against Liquor Leak
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively.
- Trial name
- NCT01355627
- Testing
- TachoSil®, Current Practice
- Where
- 39 sites in Austria, Belgium and 9 more
- Volunteers
- 726 people
- Sponsor
- Takeda
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
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a…
- Trial name
- ENCASE-II (NCT04086550)
- Testing
- LIQOSEAL, DuraSeal, Adherus
- Where
- 17 sites in United States, Austria and 5 more
- Volunteers
- 228 people
- Sponsor
- Polyganics BV
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 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
CSF Leak
The Paediatric EVICEL® Neuro Study
The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight…
- Trial name
- NCT02309645
- Testing
- EVICEL® Fibrin Sealant, Sutures Only
- Where
- 7 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Adenoma Pituitary, CSF Leakage
Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery
Postoperative cerebrospinal fluid (CSF) leakage is a well-known complication that might occur after transnasal transsphenoidal adenomectomy at an incidence of 0.5-15% according to different literature reports.
- Trial name
- NCT05682391
- Testing
- Bed rest
- Where
- Taiwan
- Volunteers
- 180 people
- Sponsor
- National Taiwan University Hospital
Cerebrospinal Fluid Leakage, Subdural
Study to Evaluate Safety & Effectiveness of Spinal Sealant
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
- Trial name
- NCT00444067
- Testing
- Spinal Sealant, Standard of Care
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Integra LifeSciences Corporation
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
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 Leakage
Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery
Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication.
- Trial name
- NCT02382692
- Where
- Switzerland
- Volunteers
- 31 people
- Sponsor
- University of Zurich
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
Hydrocephalus
Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable.
- Trial name
- NCT02408757
- Testing
- Sonographic monitoring
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Cranial Sutures; Closure
L-PRF in Cranial Surgery
The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.
- Trial name
- NCT03812120
- Testing
- Dural closure with L-PRF, Dural closure with classical fibrin sealants
- Where
- Belgium
- Volunteers
- 350 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Quality of Life
Lumbar Drain After Endoscopic Surgery of the Skull Base
The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of…
- Trial name
- NCT03163134
- Testing
- Lumbar Drain
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- University of Pittsburgh
CerebroSpinal Fluid (CSF) Leak
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base.
- Trial name
- NoSeal (NCT07216157)
- Testing
- Standard multilayer closure without sealant, Fibrin sealant application, Synthetic polyethylene glycol-based sealant
- Where
- Poland
- Volunteers
- 225 people
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
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
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
Cerebrospinal Fluid Leak
Acetazolamide for the Prevention of Post Operative CSF Leak
The purpose of this research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).
- Trial name
- NCT04351061
- Testing
- Acetazolamide
- Where
- United States
- Sponsor
- University of Miami