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Clinical trials for Gelatin sponge

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   44336   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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    4 result(s) found for: Gelatin sponge. Displaying page 1 of 1.
    EudraCT Number: 2010-020202-16 Sponsor Protocol Number: FC-002 Start Date*: 2010-11-19
    Sponsor Name:ProFibrix BV
    Full Title: A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis in the Netherlands
    Medical condition: Hepatic resection or soft tissue dissection
    Disease: Version SOC Term Classification Code Term Level
    12.1 10042609 Surgery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2011-006174-47 Sponsor Protocol Number: FC-004 Start Date*: 2012-06-08
    Sponsor Name:ProFibrix BV
    Full Title: A Phase 3, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Haemostasis
    Medical condition: Intraoperative Surgical Hemostasis (Spinal Surgery, Vascular Surgery, Hepatic resection, Soft tissue dissection)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) GB (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2014-000816-32 Sponsor Protocol Number: FC-005 Start Date*: 2014-10-17
    Sponsor Name:ProFibrix, A wholly owned subsidary of the Medicines Company
    Full Title: A Phase 3b, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ (Raplixa™) and Tachosil® in Surgical Hemostasis during Hepatic Resection
    Medical condition: Hepatic surgery specifically, hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical pro...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10053001 Surgical haemostasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003413-32 Sponsor Protocol Number: CRAD001A2310 Start Date*: 2006-01-31
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 24-month, multicenter, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0g MMF with st...
    Medical condition: de novo heart transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) IT (Completed) DK (Prematurely Ended) BE (Completed) AT (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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