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Clinical trials for 2009-010095-23

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
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    • 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   43865   clinical trials with a EudraCT protocol, of which   7286   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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    1 result(s) found for: 2009-010095-23. Displaying page 1 of 1.
    EudraCT Number: 2009-010095-23 Sponsor Protocol Number: AA-GYN-002 Start Date*: 2009-07-06
    Sponsor Name:Omrix Biopharmaceuticals Ltd
    Full Title: A prospective, controlled, randomized, multi-center, pivotal study evaluating the safety and efficacy of ADHEXIL in prevention and/or reduction of adhesions in gynecology surgery
    Medical condition: Adhesions in gynecology surgery. Surgeries involved will be ovarian cystectomy, endometriosis, inflammation, adhesiolysis Ovarian adhesion MedDRA 10067156 Tubal rupture MedDRA 10067553
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014778 Endometriosis LLT
    9.1 10004433 Benign ovarian tumour LLT
    9.1 10053865 Benign fallopian tube neoplasm LLT
    9.1 10050697 Fallopian tube cyst LLT
    9.1 10061855 Fallopian tube neoplasm LLT
    9.1 10048991 Ovarian adenoma LLT
    9.1 10033132 Ovarian cyst LLT
    9.1 10033136 Ovarian cyst ruptured LLT
    9.1 10064257 Ovarian fibroma LLT
    9.1 10033236 Ovarian germ cell teratoma benign LLT
    9.1 10061535 Ovarian neoplasm LLT
    9.1 10052456 Parovarian cyst LLT
    9.1 10036049 Polycystic ovaries LLT
    9.1 10033139 Ovarian disorder LLT
    9.1 10033263 Ovarian haematoma LLT
    9.1 10065741 Ovarian haemorrhage LLT
    9.1 10058823 Ovarian mass LLT
    9.1 10033277 Ovarian prolapse LLT
    9.1 10033279 Ovarian rupture LLT
    9.1 10046988 Varicocele ovarian LLT
    9.1 10052094 Fallopian tube disorder LLT
    9.1 10065789 Fallopian tube obstruction LLT
    9.1 10065790 Fallopian tube perforation LLT
    9.1 10065791 Fallopian tube stenosis LLT
    9.1 10050468 Haematosalpinx LLT
    9.1 10061071 Congenital ovarian anomaly LLT
    9.1 10061062 Congenital fallopian tube anomaly LLT
    11.1 10067156 PT
    9.1 10060781 Haemorrhagic ovarian cyst LLT
    11.1 10067553 PT
    9.1 10033157 Ovarian enlargement LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
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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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