Clinical trials: CSF Leak, open to volunteers
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
CerebroSpinal Fluid (CSF) Leak
The Freiburg Registry on SpontanEous IntercrAnial Hypotension (SIH) & Post-duraL Puncture Headache (PDPH)
Spinal CSF leaks are considered as rare disease. They cause a variety of symptoms, mainly culminating in a chronic headache syndrome. Crucially, yet often disregarded, the disease holds the potential for cure.
- Trial name
- SEAL (NCT06711731)
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- University Hospital Freiburg
CSF Leak
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
- Trial name
- CSF (NCT07368348)
- Testing
- Internal Nasal Splint-Supported Free Graft, Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Kafrelsheikh University
Chronic Subdural Hematoma
Spinal CSF Leaks in Chronic Subdural Hematoma
Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000.
- Trial name
- SPICE (NCT06323434)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- University of Freiburg
Sellar Tumor, Endonasal Surgery
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month…
- Conditions
- Sellar Tumor, Endonasal Surgery, Csf Leakage
- Trial name
- EEEA-AMSBP (NCT07539792)
- Testing
- Absorbable and moldable skull base support plate
- Where
- 8 sites in China
- Volunteers
- 126 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Brain Tumor Adult, Brain Tumor Benign
Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
Cerebrospinal fluid is a clear fluid that surrounds and protects the brain. During surgery for brain tumors, neurosurgeons often need to open the covering of the brain (the dura) to reach the tumor.
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, CerebroSpinal Fluid (CSF) Leak, Craniotomy
- Trial name
- CSF-IMR (NCT07411690)
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- Medical University of Warsaw
Skull Base
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
This study is a randomized controlled trial conducted across multiple centers. Due to the anatomical and pathological complexity of endoscopic endonasal skull base surgery, the study scope was restricted to the midline anterior…
- Trial name
- BRO (NCT07465861)
- Testing
- non-bed-rest, 2-day bed-rest, 1-day bed-rest
- Volunteers
- 316 people
- Sponsor
- The Affiliated Hospital of Qingdao University
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
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
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 (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
Cerebrospinal Fluid Leak, Dural Tear
Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery
The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and…
- Trial name
- NCT07092267
- Testing
- ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
- Volunteers
- 20 people
- Sponsor
- Nurami Medical Ltd