Clinical trials: CSF Leak
Pituitary Tumor, Cerebrospinal Fluid Leakage
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the…
- Trial name
- NCT06472505
- Testing
- polyglycolic acid(Neoveil)
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- National Taiwan University Hospital
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
Head Injury, Subarachnoid Hemorrhage
Influence of Drainage on EVD ICP-signal
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer.
- Trial name
- NCT03164434
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
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.
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
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
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
Cerebrospinal Fluid Leak
Post-market Assessment of Biodesign Dural Repair Grafts
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
- Trial name
- NCT04057157
- Testing
- Biodesign Dural or Duraplasty Repair Grafts
- Where
- 3 sites in United States, Canada and 1 more
- Volunteers
- 128 people
- Sponsor
- Cook Research Incorporated
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
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
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 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
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.
CSF Leakage
Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak
Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive.
- Trial name
- NCT04784169
- Testing
- free middle turbinate flap, vascularized nasoseptal flap
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Cerebrospinal Fluid Leak
The Efficacy and Safety of a Latest Dural Substitute
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group.
- Trial name
- ESLO (NCT04490629)
- Testing
- Lyoplant Onlay, DURAFORM
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
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
Intraventricular Neoplasm
Observational Pilot Study With TachoSil as a Ventricular Sealant
The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.
- Trial name
- NCT05717335
- Testing
- TachoSil
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Germans Trias i Pujol Hospital