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PneumRX registry

  • Research type

    Research Study

  • Full title

    CLN0014 Rev C All comers Post Marketing study collecting long term safety and effectiveness data on the use of RePneu coils for the treatment of severe emphysema

  • IRAS ID

    181479

  • Contact name

    Anthony de Soyza

  • Contact email

    anthony.de-soyza@ncl.ac.uk

  • Sponsor organisation

    Biocompatibles UK Ltd

  • Clinicaltrials.gov Identifier

    NCT01806636

  • Duration of Study in the UK

    6 years, 3 months, 1 days

  • Research summary

    This longitudinal cohort study is a post market observational, prospective, multicenter cohort study. It is designed to evaluate patient experience with the RePneu™ device for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. It aligns to a European study and registry allowing UK experiences to be benchmarked. In addition, the study will collect information that will serve as the foundation for a cost effectiveness analysis.
    Investigators will be board certified physicians who are interventional
    bronchoscopists or thoracic surgeons. Participating sites will have facilities that support the practice of interventional bronchoscopy and offer the RePneu
    procedure.
    Study participants will be patients who consent to have the RePneu procedure
    and with clinical data being collected in the Study.
    Participating sites will submit de-identified
    Participant data via electronic case
    report forms (eCRFs). The information collected by participating sites will be
    placed in a web-based
    database. Quality of Life (QOL) measures including
    Participant experience and satisfaction following this procedure will also be
    collected.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    15/NE/0350

  • Date of REC Opinion

    3 Nov 2015

  • REC opinion

    Favourable Opinion