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The goal of this clinical trial is to learn if the FlexAblateâ„¢ 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 FlexAblateâ„¢ 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 FlexAblateâ„¢ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transbronchoscopic Microwave Ablation | Experimental | The FlexAblateâ„¢ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave Ablation | Device | FlexAblate Microwave Transbronchial Ablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of procedure |
| Ablation Technical Success |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation zone size assessment | Evaluation of the ablation zone size defined as the radiologic region or zone of induced treatment effect by CT imaging. | Discharge - Day 1 |
| Assessment of Local Control | Assessment of target tumour local control defined as local suspicious growth under CT imaging at the originally ablated target tumour within or abutting the ablation zone. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annette Kent, PhD | Contact | +353868584016 | clinical@endowave.ie |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré - Hartmann | Recruiting | Paris | France |
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Prospective, single-arm, non-randomised clinical investigation.
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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.
| 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. | 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. | 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"). | 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). | 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. | 1 month |
| 12 months |
| Device user experience | Device user experience questionnaire completed at the time of the procedure by the investigator or physician performing the ablation. | Day of procedure |
| Assessment of pulmonary function | Completion of Pulmonary Function Tests to assess pulmonary function. | 12 months |
| Ablation ablative margin assessment | Evaluation of the size of the ablation margin defined as the ablation beyond the borders of the tumor by CT imaging. | Discharge - Day 1 |
| St. Bartholomew's Hospital | Recruiting | London | United Kingdom |
|
| University College London Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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