Clinical trials: CerebroSpinal Fluid (CSF) Leak
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.
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
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
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 Leak
Post-market Assessment of Biodesign Dural Repair Grafts
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
- Trial name
- NCT04057157
- Testing
- Biodesign Dural or Duraplasty Repair Grafts
- Where
- 3 sites in United States, Canada and 1 more
- Volunteers
- 128 people
- Sponsor
- Cook Research Incorporated
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 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.
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
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 Leak
Perioperative CSF Leak Management - an Opinion Study
Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques.
- Trial name
- NCT04124523
- Where
- France
- Volunteers
- 153 people
- Sponsor
- University Hospital, Montpellier
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
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 Leak
Acetazolamide to Prevent 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
- NCT02902133
- Testing
- Acetazolamide
- Sponsor
- University of Miami
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 Leakage
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive.
- Trial name
- NCT04784169
- Testing
- free middle turbinate flap, vascularized nasoseptal flap
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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
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
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