Clinical trials: Cerebrospinal Fluid Leaks
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
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
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
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 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.
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
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
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
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
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 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.
Hydrocephalus
Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
As elaborated above only one study reported ultrasonographic changes of the width of the lateral ventricle during clamping of EVD/LD and indicated that ultrasound monitoring might be suitable.
- Trial name
- NCT02408757
- Testing
- Sonographic monitoring
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
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 Cord Injury
Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of mean arterial pressure…
- Trial name
- NCT02495545
- Testing
- CSFD and elevation of MAP, Maintenance of MAP
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
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.
Dural Sealing
DuraSeal Exact Spine Sealant System Post-Approval Study
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
- Trial name
- DuraSeal PAS (NCT01410864)
- Testing
- DuraSeal Exact Spine Sealant System, Control
- Where
- 36 sites in United States
- Volunteers
- 924 people
- Sponsor
- Integra LifeSciences Corporation
CSF Leakage
Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment
As limited data is available locally and internationally regarding early Lumbar drain and its effect on duration of CSF leak we have decided to compare it conservative treatment.
- Trial name
- NCT05792683
- Testing
- lumbar drain
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Rawalpindi Medical College
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
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