Clinical trials: Cerebrospinal Fluid Leakage
Csf Leakage
Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery
A 65 year old female participant , right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, the participant underwent an MRI and it was found a sellar lesion that compressed the optic…
- Trial name
- NCT03280849
- Testing
- Implant of bilaminar chitosan scaffold
- Where
- Mexico
- Volunteers
- 1 people
- Sponsor
- University of Guadalajara
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 Leakage
Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery
Sinus surgery is a common procedure. A potential complication is injuring the membranes of the brain. This can lead to leakage of brain fluid through the nose. We would like to estimate the incident rates of that complication.
- Trial name
- NCT02382692
- Where
- Switzerland
- Volunteers
- 31 people
- Sponsor
- University of Zurich
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
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
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
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
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 (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
CSF Leak, CSF Pressure Increased
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
Dear Sir or Madam, You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative…
- Conditions
- CSF Leak, CSF Pressure Increased, CSF Circulation Disorder, Puncture
- Trial name
- PSEUDO (NCT07614399)
- Testing
- Lumbar Drainage, Pseudomeningocele Puncture, Puncture with Fibrin Glue Application
- Where
- Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Charles University, Czech Republic
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
Cerebrospinal Fluid Leak
Mobilisation Algorithm After Incidental Durotomy
Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache, photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous wound) after a primary repair should be considered for…
- Trial name
- NCT02927782
- Testing
- Early Mobilization, Bed Rest
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- Balgrist University Hospital
Cerebrospinal Fluid Leak
Acetazolamide to Prevent 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
- NCT02902133
- Testing
- Acetazolamide
- Sponsor
- University of Miami
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
Cranial Nerve Diseases, Facial Neuralgia
CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
Even at centers with very large experience, the risk of cerebrospinal fluid (CSF) leakage in surgery for microvascular decompression is reported up to 3%. Prevention of leakage is important since meningitis may follow.
- Conditions
- Cranial Nerve Diseases, Facial Neuralgia, Trigeminal Neuralgia, Hemifacial Spasm
- Trial name
- NCT01932255
- Testing
- prophylactic spinal tap, no prophylactic spinal tap
- Sponsor
- St. Olavs Hospital
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
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
Posterior Fossa Surgery
Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
Posterior fossa surgery represents on of the most demanding procedure in neurosurgery. Retrosygmoid (RS), key-hole retrosygmoid (KR) and cerebellar hemispheric (CH) are the most common approaches used to access in this area.
- Trial name
- O'Ring (NCT06620952)
- Testing
- O-ring technique
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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.