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Table 4 Reduction in mean perfused and total fibroid volumes at 3 months (Per-Protocol and Full Analysis datasets)

From: Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study

 

Per-Protocol

Full Analysis set

Baseline

3 Months

% Reduction from baseline

P valuea

Baseline

3 Months

% Reduction from baseline

P valuea

Number of MRI-evaluable fibroids

89

88

  

89

89

  

Number of subjects

49

48

  

49

49

  

Perfused fibroid volume (cc)

18.3 ± 20.6

9.5

(0.3–77.0)

5.5 ± 9.2

1.6

(0.0–45.7)

68.8 ± 27.8 %

77.1 %

(−33.3–100 %)

<0.0001

18.3 ± 20.6

9.5

(0.3–77.0)

5.8 ± 9.6

1.6

(0.0–45.7)

68.1 ± 28.6 %

76.9 %

(−33.3–100 %)

<0.0001

Total fibroid volume (cc)

18.8 ± 21.4

9.5

(0.3–77.0)

7.7 ± 11.8

1.9

(0.0–56.3)

55.3 ± 37.2 %

63.1 %

(−85.7–100 %)

<0.0001

18.8 ± 21.4

9.5

(0.3–77.0)

8.0 ± 12.0

1.9

(0.0–56.3)

54.7 ± 37.4 %

62.5 %

(−85.7–100 %)

<0.0001

  1. Data are mean ± standard deviation; median; (range)
  2. aWilcoxon signed-rank test, null hypothesis of no change