AB1MALTISC-UK

• Research type

  Research Study

• Full title

  Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (AB1MALTISC) - UK

• IRAS ID

  343239

• Contact name

  Pallav L Shah

• Contact email

  pallav.shah@imperial.ac.uk

• Sponsor organisation

  Creo Medical Limited

• Duration of Study in the UK

  1 years, 5 months, 0 days

• Research summary

  Lung cancer is the leading cause of cancer-related death in the world.This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, we are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours.
  The aim of this study is to evaluate the safety of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional
  procedure to their surgical procedure.
  The study, funded by Creo Medical, will be conducted at a single site in the UK, and will involve up to 18 participants. Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation. There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital’s routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.

  Participation in this study has the potential to provide the following benefits for other people
  who have the same medical condition:

  - The option of choosing microwave ablation as an alternative treatment for lung tumours and
  avoiding a major surgical procedure.
  - Shorter patient recovery times.
  - Reduced incidence of complications.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  24/EE/0276

• Date of REC Opinion

  4 Feb 2025

• REC opinion

  Further Information Favourable Opinion