AB1MALT
Research type
Research Study
Full title
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue.
IRAS ID
307228
Contact name
Pallav Shah
Contact email
Sponsor organisation
Creo Medical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Lung Cancer is one of the most common malignancies (cancers) and it has the second highest death rate of any neoplasm (tumour) globally.
This study is designed to assess whether microwave ablation (heating to destructive temperature) using the Creo Medical MicroBlate Flex (AB1) System can be used to avoid the need for participants who have lung nodules to undergo surgery. This study is not randomised and there is no control or placebo group, meaning that it is planned that all participants in the study will undergo microwave ablation.
The study will answer questions related to safety and performance with objectives including assessment of technical success (delivery of microwave energy to ablate lung tissue) and assessment of device related adverse events (meaning any harm to the participant).
Potential benefits to the participant include, effective bronchoscopic (procedure performed with a small flexible tube with camera to examine the airways) microwave ablation of the lung lesion (without the need for surgery), reduced duration of hospital stay and improved quality of life.
Potential future benefits for other people who have the same medical conditions include the choice to select bronchoscopic microwave ablation treatments of lung tissue lesions and the avoidance of surgery for future patients who are surgical candidates and improved quality of life.
The MicroBlate Flex (AB1) System has been approved for use in Europe. The study, funded by Creo Medical, will be conducted in UK, Europe and possibly the US, and will involve up to 32 participants. This is a post-market prospective, single-arm, multicenter, open-label, non-randomized study.
The participation in this study will last up to a maximum of approximately 12 months. The participation will include a screening visit, a pre-procedural assessment, a bronchoscopy procedure that includes MicroBlate Flex treatment, a post-procedural assessment and 5 follow-up visits at, 31-45 days, 3 months, 6 months, 9 months and 12 months.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0107
Date of REC Opinion
1 Jul 2022
REC opinion
Further Information Favourable Opinion