Clinical trials: CerebroSpinal Fluid (CSF) Leak
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
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
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
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
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
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
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
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
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
Surgery
Hemopatch Safety and Efficacy Evaluation Versus Standard Practice for Sealing the Dura in Cerebrospinal Fluid Leaks
Posterior fossa surgeries are generally complicated by difficulties in creating a watertight dural closure, which often requires the use of dural substitutes.
- Trial name
- NCT04419597
- Testing
- HEMOPATCH, Standard of care
- Where
- Spain
- Volunteers
- 122 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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