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Clinical trials for Cranial fossa

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    5 result(s) found for: Cranial fossa. Displaying page 1 of 1.
    EudraCT Number: 2014-003954-15 Sponsor Protocol Number: BIOS-14-002 Start Date*: 2015-05-06
    Sponsor Name:Ethicon, Inc.
    Full Title: A single blinded, randomized, controlled study to evaluate the safety and effectiveness of EVICEL® Fibrin sealant (Human) compared to a Hydrogel sealant as an adjunct to sutured dural repair
    Medical condition: Cerebrospinal fluid leakage in posterior fossa or supratentorial procedures (craniectomy or craniotomy) during neurosurgery
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003558-26 Sponsor Protocol Number: BIOS-13-006 Start Date*: 2014-07-21
    Sponsor Name:Ethicon Inc
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating the Safety and Efficacy of EVICEL® used for Suture-line sealing in Dura-Mater Closure during Paediatric Neurosurgical Cranial Procedures
    Medical condition: Subjects undergoing neurosurgical cranial procedures, requiring water-tight closures (suture-line sealing) in dura-mater during the surgery
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2009-010004-28 Sponsor Protocol Number: ACNS0331 Start Date*: 2010-04-14
    Sponsor Name:COG
    Full Title: ACNS0331 A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblas...
    Medical condition: Medulloblastoom standard risk
    Disease: Version SOC Term Classification Code Term Level
    12.0 10027107 Medulloblastoma LLT
    12.0 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-016501-41 Sponsor Protocol Number: 400-09-001 Start Date*: 2010-06-29
    Sponsor Name:Omrix Biopharmaceuticals Ltd
    Full Title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
    Medical condition: tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Completed) FI (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-013056-71 Sponsor Protocol Number: TC-2402-038-SP Start Date*: 2010-03-10
    Sponsor Name:Takeda Pharma A/S
    Full Title: TachoSil versus current practice in dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised...
    Medical condition: Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10067908 Neurosurgery PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) FI (Prematurely Ended) SE (Completed) DE (Completed) NL (Completed) GR (Completed) ES (Completed) AT (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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