Clinical Trials Logo

Cerebrospinal Fluid Leak clinical trials

View clinical trials related to Cerebrospinal Fluid Leak.

Filter by:

NCT ID: NCT06419855 Not yet recruiting - Clinical trials for Cerebrospinal Fluid Leakage

Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair

Start date: July 2024
Phase:
Study type: Observational

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; this material allows the regeneration of tissue that makes up one of the layers of the brain that was affected before or during surgery. The primary hypothesis of this study is that there will be no more than a 10% difference in outcomes between the BIOSCAFF®H device and the active comparator, DuraGen®, with respect to the incidence of cerebrospinal fluid leak or the presence of pseudomeningocele.

NCT ID: NCT06406790 Not yet recruiting - Clinical trials for Leak, Cerebrospinal Fluid

CraniSeal Post Approval Study

Start date: June 2024
Phase: Phase 4
Study type: Interventional

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 to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

NCT ID: NCT06323434 Not yet recruiting - Clinical trials for Chronic Subdural Hematoma

Spinal CSF Leaks in Chronic Subdural Hematoma

SPICE
Start date: April 2024
Phase:
Study type: Observational

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. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population. The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks. Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH. Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures.

NCT ID: NCT05898074 Not yet recruiting - Clinical trials for Skull Base Neoplasms

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

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 skull base surgery and the impact on patient and sinonasal morbidity.

NCT ID: NCT05801393 Not yet recruiting - Clinical trials for Imaging of Active CSF Rhinorrhea

HRCT, CT Cisternography and MR Cisternography in Assessment of CSF Rhinorrhea

Start date: May 1, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05792683 Recruiting - CSF Leakage Clinical Trials

Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment

Start date: February 21, 2023
Phase: N/A
Study type: Interventional

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. By providing CSF an alternative route for drainage, the fistula site will remain dry. Leakage site won't be facing CSF pressure, and this will promote early healing of the wound.

NCT ID: NCT05682391 Enrolling by invitation - CSF Leakage Clinical Trials

Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

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. Persistent CSF leakage may lead to intracranial hypotension or meningitis, therefore aggressive management is mandatory. The treatment is immediate repair during transsphenoidal surgery once intraoperative CSF leakage is identified, with the adjunct of postoperative bed rest and/or lumbar drainage. However, due to the advances in endoscopic endonasal skull base surgery, some surgical teams have advocated that postoperative bed rest may not be necessary if appropriate repair have been performed. High-flow CSF leakage typically occurs in an extended endonasal approach to the anterior or posterior cranial fossa, whereas CSF leakage resulting from transsphenoidal pituitary surgery is usually easier to be repaired. Bed rest is stressful management for patients and poses increased risks in many ways, such as the need for an indwelling urinary catheter, musculoskeletal pain, affected sleep quality, and increased possibility of thromboembolism. It is crucial that the duration of bed rest be cut short or totally avoided if clinically acceptable. In reviewing the literature, there is insufficient evidence supporting the routine use of postoperative bed rest after CSF leakage repair in transsphenoidal surgery. This study aims to compare the efficacy of successful CSF leakage repair with or without postoperative bed rest with an open-label randomized trial design.

NCT ID: NCT05024643 Completed - CSF Leakage Clinical Trials

Endoscopic Repair of Frontal Sinus CSF Leak

Start date: May 1, 2015
Phase:
Study type: Observational

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.

NCT ID: NCT04923867 Active, not recruiting - Clinical trials for Cerebrospinal Fluid Leak

Suturable DuraGen™ PMCF Study

Start date: April 28, 2021
Phase:
Study type: Observational

The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

NCT ID: NCT04784169 Not yet recruiting - CSF Leakage Clinical Trials

Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak

Start date: April 2021
Phase: N/A
Study type: Interventional

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. The overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing CSF leak during an endoscopic approach.