Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT)

Primary Safety Objective:

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 compared to the adverse events

identified in the peer-reviewed literature (CER) or risk assessment for the

ablation of lung soft tissue, in subjects who are not candidates for, or

decline, surgical resection.



Primary Safety Endpoint:

Identification of serious device-related adverse events related to the use of

the AB1 system from up to 30 days after the ablation procedure (number and

nature of serious adverse events, both device- and procedure-related, will be

identified) including but not limited to:



• Moderate bleeding (intervention required such as use of balloon tamponade or

Surgicel) or severe bleeding (prolonged monitoring necessary or fatal bleeding)

• Pneumothorax

• Failure of extubation

• ICU admission for respiratory failure within 30 days

• Death within 30 days.



Primary Performance Objective:

To evaluate the ability of the AB1 instrument to bronchoscopically be

positioned in the targeted lung tissue and deliver scheduled microwave energy

to the targeted tissue.



Primary Performance Endpoint:

Initial technical success, defined as successful bronchoscopic access by the

AB1 instrument of the target tissue, delivery of the scheduled microwave energy

to the target tissue (per pre-specified target) and confirmed ablation as

evidenced by assessment of CT on day 0 (post ablation) or up to day 30 patient

visit.



The criterion for meeting the Performance (efficacy) endpoint excludes study

system malfunctions.

Secondary Safety Objective:

To assess the clinical safety of AB1 system ablation of pulmonary nodules.



Secondary Safety Endpoint:

Identification of all device-related, procedure related and other adverse

events related to bronchoscopic microwave ablation interventions using the AB1

system with follow-up at 1, 7 and 31 to 45 days, and at 3, 6, 9, and 12 months,

post-ablation.



Secondary Performance (Efficacy) Objectives:

To assess the clinical efficacy of AB1 system ablation of pulmonary nodules.



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 human lung

tissue using the AB1 System to deliver microwave energy for the same period,

during the proposed clinical study.



To evaluate the impact of using the AB1 system on patient quality of life, in

subjects undergoing pulmonary nodule ablation.



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 Outcome Measures:

1. Rate of recurrence at all time points as determined by the multidisciplinary

team (MDT) or tumour board.

2. European Organization for Research and Treatment of Cancer Quality of life

questionnaire - Cancer (EORTC) QLQ- C. 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: Within 2 months prior to the ablation, on the day of the ablation (prior

to ablation), on the day after ablation, and 31 to 45 days, 6 months and 12

months post-ablation].

3. 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. [Time Frame: Within 2 months prior to the ablation, on the day

of the ablation (prior to ablation), on the day after ablation, and 31 to 45

days, 6 months and 12 months post-ablation].

4. Patient-reported pain rating on a visual analogue scale from 0 to 10 (where

0 is no pain and 10 is the most severe pain) [Time Frame: Within 2 months prior

to the ablation, on the day of the ablation (prior to ablation), on the day

after ablation, and at 31 to 45 days post-ablation].

5. Assessment/visualization/quantification of the dimensions of the ablated

tissue to confirm, correct or add to the IFU-reported relationship between AB1

ablation time and dimensions and volume of the ablated tissue, per

pre-specified target.

6. Procedural Time.

7. Assessment of ease of system use (clinician questionnaires). Questionnaires

to be completed by clinicians, rating their responses on a Likert scale of 1 to

7, with 1 being "extremely easy" and 7 being "extremely difficult".