Clinical trials: CSF Leak
Dural Tear, Cerebrospinal Fluid Leak
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery.
- Trial name
- NEOART (NCT04145544)
- Testing
- Implantation of the ArtiFascia®, Implantation of other commercial suturable dural substitute
- Where
- 9 sites in Belgium, Czechia and 3 more
- Volunteers
- 92 people
- Sponsor
- Nurami Medical Ltd
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.
Postdural Puncture Headache, Post-Lumbar Puncture Headache
Incidence of Headache Following an Unintentional Dural Puncture
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
- Conditions
- Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
- Trial name
- NCT01977898
- Testing
- Morphine, Saline
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Northwestern University
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 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.
Cerebrospinal Fluid Leaks
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF leaks to that of a simulated procedure without…
- Trial name
- NCT03276975
- Testing
- TISSEEL
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Duke University
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
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
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 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
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