Table 2.
Endpoint | Outcome |
---|---|
Primary endpoints | |
Technical success | 100% (11/11 tumors) |
Technique efficacy | 100% (9/9 tumors) |
Secondary endpoints | |
Tumor recurrence | 0% (0/11 tumors) |
Length of hospital stay | 100% discharged within 24 h (11/11 procedures) |
Hospital readmission <30 days | 1 readmission within 30 days (1/11 ablations, 9%) |
COPD exacerbation, with hospital discharge after 2 days | |
AEs <30 days | 35 minor AEs |
No pneumothorax, bronchial fistula, or pleural effusion | |
SAEs <30 days | 2 SAEs: |
Day 9, COPD exacerbation, probably procedure-related and unlikely device-related | |
Day 15, unexpected death of unknown cause, probably procedure-related and possibly device-related | |
Exploratory endpoints | |
Quality of life (QLQ-C30, QLQ-LC13) | No MCID in standardized scores between screening and month 12, except: |
Discreet improvement QLQ-C30 Global Health Status | |
Discreet improvement QLQ-LC13 Dyspnea | |
Discreet deterioration QLQ-C30 Fatigue | |
Pain (numeric pain rating scale) | Pain scores low and stable between procedure day and day 30 |
ECOG performance status | Performance status “good” and stable between procedure day and month 12 |
Pulmonary function | Indices stable or slightly improved between screening visit and month 6, 12 |
COPD, chronic obstructive pulmonary disease; MCID, minimal clinically important difference.