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CSF Leak clinical trials

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NCT ID: NCT04503161 Withdrawn - CSF Leak Clinical Trials

The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery

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

This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.

NCT ID: NCT02876614 Completed - Fistula Clinical Trials

Value of Radionuclide Cisternography

VERTICAL
Start date: January 2005
Phase: N/A
Study type: Observational

Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus. In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF unlike other reference tests. In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and throat of the patient to collect a possible flow of CSF. These samples are analysed by radioactivity measurements and bring an added value to the exam. The interest of this examination for management of CSF leak/fistula remains unclear. The aim of this study is to identify and analyse results of all RC examinations performed since 2005 in the Nuclear Medicine department of the Neurological Hospital. The full analysis of patients will allow discussing the role of RC in management of CSF leak/fistulae in clinical practice.

NCT ID: NCT02309645 Terminated - CSF Leak Clinical Trials

The Paediatric EVICEL® Neuro Study

Start date: October 1, 2014
Phase: Phase 3
Study type: Interventional

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 closure.