lung cancer lung carcinoma
Conditions
Interventions
The subject device, the AB1 electrosurgical system is CE Marked for soft tissue
ablation. The device has not been modified and is being used in accordance with
its intended purpose.
The MicroBlate
Sponsors
Creo Medical Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients who: 1. Have signed informed consent. 2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. 3. Are >= 18 years old. 4. Have lung lesion(s)/nodule(s) which are histopathologically confirmed as cancer. 5. Have soft tissue lung lesion(s): • 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure. 8. Subject is willing and able to comply with the study protocol requirements. 9. Are assigned an ASA (American Society of Anaesthesiologists) score of
Exclusion criteria
Exclusion criteria: Patients who: 1. Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) *Central Zone* (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic & laryngeal nerves). 2. Are pregnant or breast feeding, as determined by standard site practices. 3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study. 4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject. 5. Have an expected survival less than 12 months. 6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet count 50mmHg). 9. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can*t be stopped or temporarily withheld. 10. Subject had a prior pneumonectomy. 11. Diagnosis of Small Cell Lung Cancer. 12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation. 13. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion. 14. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety objectives are as follows: Stage A - Ablate (Day 0) & Resect (Day 0) To assess and characterize any serious device-related intra-procedural adverse events associated with the delivery of microwave energy by the AB1 system in subjects undergoing bronchoscopic pulmonary nodule ablation prior to the first surgical incision for the resection. Stage B - Ablate (Day 0) & Resect (Resection Day 7-21) To assess and characterize any serious device-related adverse events associated with the delivery of microwave energy by the AB1 system in subjects undergoing bronchoscopic pulmonary nodule ablation (prior to the first surgical incision for the resection), in subjects who will undergo surgical resection. The primary performance (efficacy) objective is: To evaluate the ability of the AB1 instrument to bronchoscopically be positioned in the targeted lung tissue confirmed by fluoroscopy, CBCT or direct bronchoscopic vision and deliver scheduled microwave energy to the targeted tissue. The primary safety endpoint/outcome measures are as follows: Stage A - Ablate (Day 0) & Resect (Day 0) Identification of serious device-related intra-procedural adverse events related to the use of the AB1 system on Day 0 prior to surgical resection defined by the initial skin incision (number and nature of serious adverse events, both device- and procedure related, will be identified). Stage B - Ablate (Day 0) & Resect (Resection Day 7-21) Identification of serious device-related adverse events related to the use of the AB1 system from day 0 up to initiation of surgical resection procedure (number and nature of serious adverse events, both device- and procedure related, will be identified). The primary performance endpoint/outcome is: Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance objectives: To correlate the volumes and dimensions of thermally affected tissue provided in Creo Medical AB1 instrument instructions for use (obtained in ex vivo porcine lung tissue) with the dimensions and volumes measured in lung nodules using the AB1 System to deliver microwave energy for the same period, during the proposed clinical study. To evaluate the ease of use of the AB1 System, including physician assessments of set-up, treatment selection, advancement and withdrawal of the AB1 Instrument from the bronchoscope, and electrosurgical system clean up, and instrument disposal. Secondary performance endpoints/outcome measures: 1. Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion.* 2. Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT. 3. Procedural Time 4. Assessment of ease of system use, including: a. Clarity of instructions as reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely clear* and 7 being *extremely difficult to follow*. b. Ease of set up as reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being *extremely difficult.* c. Ease of selection of instrument from drop-down menu as reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being *extremely difficult.* d. Ease of selecting treatment (power delivery time) using the diagrams and figures provided in the IFU, as reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being *extremely difficult.* e. Ease of footswitch use to control energy delivery as reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being *extremely difficult.* f. Ease of advancing AB1 instrument through bronchoscope to target tissue as reported by clinicians on a Likert scale o | — |
Countries
Netherlands
Outcome results
None listed