Delcath Registry

  • Research type

    Research Study

  • Full title

    Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

  • IRAS ID

    145630

  • Contact name

    Kim Wharton

  • Contact email

    kimwharton@regulis.com

  • Sponsor organisation

    Delcath Systems, Inc

  • Duration of Study in the UK

    2 years, 2 months, 14 days

  • Research summary

    The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2011. This study is designed to collect the treatment outcome in patients who receive this treatment and use experience of the CHEMOSAT Kits by healthcare professionals. The safety and efficacy data from these patients is important in updating the safety profile as well as the risk/benefit of the treatment. The resource utilization information is essential in planning treatment strategy for patients.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    15/NE/0113

  • Date of REC Opinion

    15 Apr 2015

  • REC opinion

    Further Information Favourable Opinion