Clinical trials: Cerebrospinal Fluid 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
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 Drainage Catheter
Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program
The study aim is to determine whether simulation based learning would improve senior anesthesiology residents' patient care performance during the insertion and management of cerebrospinal fluid drainage catheters when compared…
- Trial name
- NCT03545984
- Testing
- Simulation-based learning, interactive problem based learning
- Volunteers
- 48 people
- Sponsor
- The Cleveland Clinic
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
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
Suturable DuraGen™ PMCF Study
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
- Trial name
- NCT04923867
- Testing
- Suturable DuraGen™
- Where
- 3 sites in United States
- Volunteers
- 106 people
- Sponsor
- Integra LifeSciences Corporation
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 Leakage
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull…
- Trial name
- NCT06419855
- Testing
- Human collagen matrix graft, Bovine collagen matrix graft
- Where
- 4 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Top Health S.A.P.I DE C.V.
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.
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
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.
Subarachnoid Haemorrhagic Stroke
Investigation of the Role of Inflammatory Markers in the Early Detection of Cerebral Vasospasm, Delayed Cerebral Ischemia, and Meningitis Associated With External Cerebrospinal Fluid Drainage After Non-Traumatic Subarachnoid Hemorrhage - A Prospective Case-Control Study
Background Non-traumatic subarachnoid haemorrhage (SAH) is frequently complicated by delayed cerebral ischaemia (DCI) and by ventriculitis/meningitis when external CSF drains are used; bedside TCCD has limited accuracy for…
- Trial name
- NCT07129603
- Where
- Hungary
- Volunteers
- 100 people
- Sponsor
- Tamas Vegh, MD
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
Spinal Epidural Hematoma, Thoracic Surgery
Risk Factors for Postoperative Spinal Epidural Hematoma Following Posterior Thoracic Spinal Surgery in a Single Institute
This is a retrospective, observational single-center study. The studies is to investigate the incidence of posterior epidural spinal hematoma(PSEH) and recognize the risk factors for it in a cohort of patients undergoing…
- Trial name
- NCT04961424
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Peking University Third Hospital
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, 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