Table 2.
Primary and secondary endpoint of the current study.
| Outcome | Novel device (n = 102) | Control (n = 102) | P-value |
|---|---|---|---|
| Primary endpoint, n (%) | |||
| Grade 1 hematoma | 8 (7.8) | 24 (23.5) | <0.01 |
| Grade 2 hematoma | 2 (2.0) | 6 (5.9) | <0.01 |
| Grade 3 hematoma | 2 (2.0) | 7 (6.8) | 0.03 |
| Secondary endpoint | |||
| Skin erosions, n (%) | 0 (0) | 9 (8.8) | <0.01 |
| Patient comfort score, mean ± SD | 7.2 ± 1.1 | 4.8± 0.8 | <0.01 |