Table 1 Results of study endpoints
Outcome | Metric | Study arm | N patients | Total resections | Summarya | Differenceb (95% CI) | p value |
|---|---|---|---|---|---|---|---|
Safety endpoint | PPA | SoC | 424 | 517 | 276 (53.4%) | 0 | – |
CADe | 417 | 700 | 377 (53.9%) | 0.5% (−5.0%, ∞)c | |||
Adenoma detection metrics | APC (overall) | SoC | 424 | 262 | 0.62 ± 1.19 | 1 | 0.01 |
CADe | 417 | 343 | 0.82 ± 1.40 | 1.33 (1.06, 1.67) | |||
APC (distal) | SoC | 424 | 121 | 0.29 ± 0.61 | 1 | 0.07 | |
CADe | 417 | 158 | 0.38 ± 0.84 | 1.32 (0.98, 1.79) | |||
APC (proximal) | SoC | 424 | 141 | 0.33 ± 0.85 | 1 | 0.05 | |
CADe | 417 | 185 | 0.44 ± 0.86 | 1.33 (1.00, 1.77) | |||
ADR | SoC | 424 | – | 152 (35.9%) | 0 | 0.03 | |
CADe | 417 | – | 180 (43.2%) | 7.3% (0.7%, 13.9%) | |||
Neoplastic polyp detection metrics | NPPC | SoC | 424 | 280 | 0.66 ± 1.20 | 1 | 0.002 |
CADe | 417 | 381 | 0.91 ± 1.48 | 1.39 (1.12, 1.73) | |||
NSP-PC | SoC | 424 | 18 | 0.04 ± 0.21 | 1 | 0.03 | |
CADe | 417 | 38 | 0.09 ± 0.46 | 2.15 (1.07, 4.32) | |||
Polyps (all) detection metrics | PDR | SoC | 424 | – | 225 (53.1%) | 0 | 0.04 |
CADe | 417 | – | 251 (60.2%) | 6.8 (0.3, 13.3) | |||
PPC (overall) | SoC | 424 | 451 | 1.06 ± 1.53 | 1 | 0.001 | |
CADe | 417 | 589 | 1.41 ± 1.85 | 1.35 (1.13, 1.61) | |||
PPC (distal) | SoC | 424 | 238 | 0.56 ± 0.94 | 1 | 0.008 | |
CADe | 417 | 315 | 0.76 ± 1.25 | 1.35 (1.08, 1.69) | |||
PPC (proximal) | SoC | 424 | 213 | 0.50 ± 0.97 | 1 | 0.02 | |
CADe | 417 | 274 | 0.66 ± 1.07 | 1.31 (1.04, 1.65) | |||
SSL detection metric | SSL-PC | SoC | 424 | 11 | 0.03 ± 0.16 | 1 | 0.006 |
CADe | 417 | 34 | 0.08 ± 0.45 | 3.30 (1.41, 7.571 |