CONVERT II

  • Research type

    Research Study

  • Full title

    An Evaluation of the AeriSeal System® for CONVERTing Collateral Ventilation Status in Patients with Severe Emphysema: The CONVERT II Trial

  • IRAS ID

    336595

  • Contact name

    Pallav Shah

  • Contact email

    Pallav.shah@ic.ac.uk

  • Sponsor organisation

    PulmonX Corporation

  • Clinicaltrials.gov Identifier

    NCT06035120

  • Duration of Study in the UK

    4 years, 0 months, 0 days

  • Research summary

    Emphysema causes destruction of the small airways in the lung, leading to lung over-inflation, difficulty taking up
    oxygen, and breathlessness. This can often be improved by implanting a valve (called the Zephyr Valve) into the most
    diseased part of your lung to improve your breathing. When the Zephyr Valve is implanted in the most diseased part of
    your lung it stops inhaled air from getting to that part of the lung, but lets air out. This causes that part of the lung to
    deflate, and as a result, the healthier part of the lung can function better, making breathing easier. Currently the Zephyr
    Valve can only be inserted into the lung when there are no open air channels between the lung compartments where
    the valve is situated. This means that patients who do have open air channels cannot currently have this valve inserted
    to improve breathing. This study is testing the use of the AeriSeal System during a bronchoscopy procedure to see if it
    is an effective technique to close the air channels between your lungs (we call it “fissure closure”) and remove the air
    flow between your lung compartments. If the closure of the fissure is successful, your doctor can then perform the
    Zephyr Valve Procedure to treat your emphysema symptoms. This study therefore combines both procedures (the
    AeriSeal System and the Zephyr Valve) to improve breathing function.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    24/LO/0094

  • Date of REC Opinion

    26 Mar 2024

  • REC opinion

    Further Information Favourable Opinion