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. 2023 Jan 18;102(3):182–193. doi: 10.1159/000528820

Table 2.

Study endpoints and outcomes

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.