AURORA

  • Research type

    Research Study

  • Full title

    A clinical Investigation in lUng canceR of the Endowave FlexAblateTM Microwave tRansbronchial Ablation System (AURORA)

  • IRAS ID

    347460

  • Contact name

    Kelvin Lau

  • Contact email

    kelvin.lau@nhs.net

  • Sponsor organisation

    Endowave Ltd

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    The Endowave FlexAblate Microwave Ablation System is a new device which has been developed for the treatment of lung cancer.

    The device is used in a procedure carried out by trained pulmonologists and/or thoracic surgeons while the patient is under general anaesthesia. The single-use FlexAblate device is navigated through the patient’s airways (bronchoscopically) using a lung navigation system to reach the target tumour. Like other microwave ablation devices, the Endowave FlexAblate system works by applying microwave energy to the target to induce controlled heating, which destroys the cancer cells. Obtaining access to the tumour via the patient’s airways avoids the risks associated with entering the patient’s lung through the chest wall. This has the potential to reduce procedure risks and provide shorter recovery times for patients, when compared to alternative treatments including surgical resection.

    This clinical study is a prospective, single-arm, non-randomised clinical investigation designed to investigate the performance, safety and clinical benefit of the bronchoscopic ablation procedure using the Endowave FlexAblate Microwave Ablation System in up to 43 patients undergoing lung ablation procedures in 5 European trial centres. The study will be wholly funded by the manufacturer Endowave Ltd. The intended patient population includes patients aged over 18 years who have been previously diagnosed with cancer in the lung (primary or secondary malignant tumours) and deemed unsuitable for surgery or are declining surgery or, patients suitable for microwave ablation procedure based on clinical assessment.

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    25/NS/0095

  • Date of REC Opinion

    1 Sep 2025

  • REC opinion

    Favourable Opinion