Clinical trials: Cerebrospinal Fluid Leakage
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
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 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
Cerebrospinal Fluid Leak
Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
- Trial name
- NCT02891070
- Testing
- FS VH S/D 500 s-apr, DuraSeal Dural Sealant
- Where
- 25 sites in United States, Czechia and 2 more
- Volunteers
- 224 people
- Sponsor
- Baxter Healthcare Corporation
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.
Acute Ischemic Stroke
Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics
This pilot interventional study investigates whether continuous cerebrospinal fluid (CSF) drainage via lumbar drain can improve cerebrovascular reactivity (CVR) in patients with acute ischemic stroke and hemodynamic failure, as…
- Trial name
- NCT07056907
- Testing
- Lumbar drain placement
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University of Zurich
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 (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
Intraventricular Neoplasm
Observational Pilot Study With TachoSil as a Ventricular Sealant
The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.
- Trial name
- NCT05717335
- Testing
- TachoSil
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Germans Trias i Pujol Hospital
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
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
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
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
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
Pituitary Tumor, Cerebrospinal Fluid Leakage
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the…
- Trial name
- NCT06472505
- Testing
- polyglycolic acid(Neoveil)
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- National Taiwan University Hospital
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
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
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