Clinical trials: CerebroSpinal Fluid (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
Spinal Duraplasty
Adherus™ Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
- Trial name
- NCT04498026
- Testing
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Where
- 14 sites in United States
- Volunteers
- 94 people
- Sponsor
- Stryker Craniomaxillofacial
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis
- Trial name
- CBCT-ENT (NCT01855425)
- Testing
- Radiation
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 96 people
- Sponsor
- Carestream Health, Inc.
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 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
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 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 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.
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
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.
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.
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.