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Cerebrospinal Fluid Leak clinical trials

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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: NCT04505423 Completed - Clinical trials for Cerebrospinal Fluid Drainage

Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement

Start date: August 3, 2020
Phase:
Study type: Observational

The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.

NCT ID: NCT04145544 Completed - Clinical trials for 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.

NEOART
Start date: January 7, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in patients requiring Dural repair following neurosurgery. Patients with planned cranial neurosurgery can take part in this study. During the surgery the soft membrane that covers the brain (called dura) is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid [CSF] leakage) and increase the risk of infections. Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a medical synthetic dural substitute that is absorbed by the body. ArtiFascia® supports the re-formation of a new dura. In addition it has a sealant layer that can reduce CSF leakage and infection.

NCT ID: NCT04124523 Completed - Clinical trials for Cerebrospinal Fluid Leak

Perioperative CSF Leak Management - an Opinion Study

Start date: January 1, 2019
Phase:
Study type: Observational

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. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence. •Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities. •Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.

NCT ID: NCT04057157 Completed - Clinical trials for Cerebrospinal Fluid Leak

Post-market Assessment of Biodesign Dural Repair Grafts

Start date: September 3, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT03566602 Completed - Clinical trials for Cerebrospinal Fluid Leak

Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

Start date: October 11, 2018
Phase: N/A
Study type: Interventional

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 surgery with a dural closure procedure.

NCT ID: NCT03545984 Completed - Clinical trials for Cerebrospinal Fluid Drainage Catheter

Evaluation of a Simulation Based Workshop in an Anesthesia Residency Program

Start date: June 5, 2014
Phase: N/A
Study type: Interventional

The study aim is to determine whether simulation based learning would improve senior anesthesiology residents' patient care performance during the insertion and management of cerebrospinal fluid drainage catheters when compared to interactive problem based learning (PBL) using the Anesthetist's Nontechnical Skills Global rating scale

NCT ID: NCT03276975 Completed - Clinical trials for Cerebrospinal Fluid Leaks

A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment

Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

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 patching material in patients with spontaneous intracranial hypotension.

NCT ID: NCT02891070 Completed - Clinical trials for 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

Start date: October 11, 2016
Phase: Phase 3
Study type: Interventional

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.

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.