Clinical trials: CSF Leak
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
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.
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
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 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
Subarachnoid Hemorrhage
Lumbar Drainage in Subarachnoid Haemorrhage
Subarachnoid haemorrhage affects approximately 8000 people per year in the UK. The average age of a patient with subarachnoid haemorrhage is 50 years, although it is often seen in younger people (25-45 years).
- Trial name
- LUMAS (NCT00842049)
- Testing
- Lumbar Drain (Medtronic lumbar drainage system), No lumbar drain
- Where
- United Kingdom
- Volunteers
- 210 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
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
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 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 (CSF) Leak, Dural Tear
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine…
- Trial name
- NEOFIX (NCT07765862)
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries., Standard of Care (Investigator Choice)
- Volunteers
- 228 people
- Sponsor
- Nurami Medical Ltd
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
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 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
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
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.
Imaging of Active CSF Rhinorrhea
HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.
- Trial name
- NCT05801393
- Testing
- CT, MRI
- Volunteers
- 50 people
- Sponsor
- Assiut University
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
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 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