Lung Cancer
Conditions
Keywords
Lung Cancer, Microwave Ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMicrowave Ablation
FlexAblate Microwave Transbronchial Ablation System
Sponsors
Endowave Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-arm, non-randomised clinical investigation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult ≥ 18 years of age who has provided signed informed consent. * Subject is able and willing to comply with the planned clinical investigation follow-up schedule * Pathological confirmed malignant nodule in the lung either primary or metastatic disease. * Target nodule is ≤ 20mm in maximum diameter. * There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure. * Subject is a candidate for an elective lung ablation procedure as determined by institutional multi-disciplinary board or equivalent. * Subject or the lesion is not suitable for surgery or patient refuses surgery.
Exclusion criteria
* Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea. * Subjects who are extremely breathless or on home oxygen therapy. * Female subjects who are pregnant or nursing. * Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening. * Subjects with prior pneumonectomy. * Subjects who have had any radiation (i.e., SBRT or EBRT) to the intended ablation zone or lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation). * Subjects who have implantable electronic devices, including pacemakers or other electronic implants. * Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP \>50mmHg). * Active active pulmonary infection at time of screening or the procedure. * Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure. * Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation. * The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Efficacy | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Technical Success | Day of procedure | Procedure technical success defined by the investigator as successful deployment, activation and removal of the ablation catheter according to the investigation plan. |
| Ablation Technical Success | At Discharge - Day 1 | 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. |
| Safety Assessment - number of device or procedure related Serious Adverse Events | Through to 1 month follow-up | Number of Serious Adverse events (SAE) related to the device or procedure associated with the use of the FlexAblate System. |
| Safety Assessment - number of device or procedure related Adverse Events (AE) | Through to 3 months | Number of Adverse Events (AE) related to the device or procedure. |
| Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30) | 12 months | Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much"). |
| Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire | 12 months | 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). |
| Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey | 1 month | Survey completed by the patient to assess their pain and satisfaction with the ablation procedure. |
Countries
France, United Kingdom
Contacts
CONTACTAnnette Kent, PhD
Outcome results
None listed