The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system. Participants in this clinical trial will be 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. Those who meet all of the eligibility criteria at a screening assessment (a review of eligibility to participate in the study includes review of information on the cancerous nodule, recording your medical history, current medications, a blood test, and quality of life assessments) will undergo the ablation treatment with FlexAblate™ Microwave Ablation System. Follow-up assessments will be at week 1 and months 1, 3, 6 and 12 will includes CT Scans (CT or "CAT" scan is a computed tomography scan), blood tests, assessment of overall health and quality of life assessments.
This is a prospective, single-arm, non-randomised clinical investigation. Up to 43 subjects will be enrolled from up to 5 sites. The clinical investigation is designed to evaluate the performance and safety of the Endowave FlexAblate™ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
FlexAblate Microwave Transbronchial Ablation System
St. Bartholomew's Hospital
London, United Kingdom
RECRUITINGTechnical Efficacy
Technical Efficacy defined as ablation of the target tumour with the ablation zone completely overlapping or encompassing the entire target tumour assessed using conventional CT imaging.
Time frame: 1 month
Procedure Technical Success
Procedure technical success defined by the investigator as successful deployment, activation and removal of the ablation catheter according to the investigation plan.
Time frame: Day of procedure
Ablation Technical Success
Ablation technical success defined as the nodule treated according to the investigation plan and covered completely by the ablation zone with an adequate margin assessed using CT imaging.
Time frame: At Discharge - Day 1
Safety Assessment - number of device or procedure related Serious Adverse Events
Number of Serious Adverse events (SAE) related to the device or procedure associated with the use of the FlexAblate System.
Time frame: Through to 1 month follow-up
Safety Assessment - number of device or procedure related Adverse Events (AE)
Number of Adverse Events (AE) related to the device or procedure.
Time frame: Through to 3 months
Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30)
Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much").
Time frame: 12 months
Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire
Patients complete the 5 level descriptive system relating to 5 dimensions of health and the EQ visual analogue scale from 0 to 100 (where 0 means the worst health you can imagine and 100 means the best health you can imagine).
Time frame: 12 months
Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey
Survey completed by the patient to assess their pain and satisfaction with the ablation procedure.
Time frame: 1 month
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