12-month outcomes of the US patient cohort in the SONATA pivotal IDE trial of transcervical ablation of uterine fibroids

Figures & data

Figure 1 The Sonata treatment device, combining an intrauterine sonography probe with a radiofrequency ablation handpiece into a single integrated handpiece.

Table 1 Baseline Patient Characteristics

Characteristic	Results
Age^1, N	125
Mean ± SD	43.5 ± 4.0
Median	44.0
Min, Max	33, 50
Ethnicity, N	125
Hispanic or Latino	21 (16.8%)
Not Hispanic or Latino	104 (83.2%)
Race^2, N	125
American Indian or Alaska Native	3 (2.4%)
Asian	2 (1.6%)
Black or African American	49 (39.2%)
Native Hawaiian or Other Pacific Islander	1 (0.8%)
White	60 (48.0%)
Other	11 (8.8%)
BMI, N^3	125
Mean ± SD	29.5 ± 6.4
Median	28.0
Min, Max	18.0, 49.8

Notes: ¹Age in years. ²Subjects indicating multiple races are counted once under each race. Percentages may add to more than 100%. ³Calculated for those with both height and weight measurements (kg/m²)

Table 2 Baseline PBAC and Fibroid Characteristics, Full Analysis Set (N=122)

Characteristic	Results
PBAC, N	122
Mean ± SD	293.5 ± 96.1
Median	281.0
Min, Max	150.2, 498.3
Total Fibroid Volume (cc), N	117
Mean ± SD	72.3 ± 90.1
Median	38.9
Min, Max	0.8, 522.9
Total Uterine Volume (cc), N	122
Mean ± SD	272.9 ± 155.8
Median	234.4
Min, Max	80.7, 868.1

Table 3 Change in PBAC Score by Visit

PBAC Score	Baseline	3 Months^a	Change	% Change
N	121	117	117	117
Mean ± SD	293.9± 96.3	175.9 ± 110.3	-119.3 ± 116.0	-38.9 ± 39.1
Median	283.6	153.4	-113.0	-44.4
Min, Max	150.2, 498.3	11.7, 647.8	-395.2, 445.1	-96.5, 219.6
P			<.0001	<.0001
		6 Months	Abs. Change	% Change
N		121	121	121
Mean ± SD		146.3 ± 102.7	-147.6 ± 105.7	-50.0 ± 30.2
Median		114.9	-133.5	-56.1
Min, Max		11.7, 519.9	-469.5, 124.9	-94.8, 38.3
P			<.0001	<.0001
		12 Months	Abs. Change	% Change
N		121	121	121
Mean ± SD		141.3 ± 107.2	-152.6 ± 125.0	-50.2 ± 42.4
Median		130.7	-145.2	-58.1
Min, Max		0.0, 902.2	-491.9, 679.4	-100.0, 304.9
P			<.0001	<.0001

Figure 2 Improvements in uterine fibroid symptom and quality of life questionnaire subscales through 12 months in the FAS population (mean values). The SSS subscale demonstrates symptom reduction whereas the HRQoL subscale denotes increases in health-related quality of life. The results on both subscales signify improvement (all P<0.0001).

Table 4 Attributes of Ablated Fibroids*

Procedure Parameter
Treated Fibroid Diameter, N	392
<1 cm	20 (5.1%)
1 – 2 cm	144 (36.7%)
>2 – 3 cm	108 (27.6%)
>3 – 4 cm	69 (17.6%)
>4 cm	51 (13.0%)
Treated Fibroid Type, N	392
Type 1	13 (3.3%)
Type 2	76 (19.4%)
Type 2-5	70 (17.9%)
Type 3	102 (26.0%)
Type 4	89 (22.7%)
Type 5	39 (9.9%)
Type 6	3 (0.8%)
Number of Fibroids/Patient, N	125
Mean±SD	3.6 ± 2.2
Median	3.0
Min, Max	1.0, 10.0
Number of Treated Fibroids/Patient, N	125
Mean±SD	3.1 ± 2.2
Median	3.0
Min, Max	1.0, 9.0
Treated Fibroid Diameter (cm), N	392
Mean±SD	2.5 ± 1.2
Median	2.3
Min, Max	0.3, 6.5

Notes: *Determined via intrauterine sonography at the time of treatment

SD, standard deviation;

Table 5 Outcomes of the Full and US-only Cohorts of the SONATA Pivotal IDE Trial

Parameter	SONATA (US+Mexico)	SONATA (US)
≥ 50% reduction in menstrual bleeding at 12 months (%)	64.8 (N=142)	65.3 (N=121)
Freedom from surgical reintervention at 12 months (%)	99.3 (N=143)	99.2 (N=122)
Mean SSS reduction at 12 months (points)	32.1 (N=135)	33.8 (N=115)
Mean HRQOL increase at 12 months (points)	43.7 (N=134)	45.8 (N=115)
Percentage of patients reporting improvement in overall fibroid symptoms (OTE questionnaire)	96.3 (N=135)	97.4 (N=115)
Mean return to normal daily activities (days)	2.2 (N=139)	2.1 (N=118)
Mean return to work (days)	3.6 (N=111)	3.7 (N=96)
Mean length of stay (hours)	2.5 (N=147)	2.5 (N=125)
Percentage of patients at least “Somewhat Satisfied” at 12 months	97.1 (N=135)	98.3 (N=115)
Percentage of patients who would at least “Probably Recommend” Sonata to a friend or family member	97.1 (N=135)	96.5 (N=115)

Table S1 List of each Institutional Review Board (IRB)

Institution Name	IRB
Arizona Gynecology Consultants	Western Institutional Review Board, IRB
Advanced Women’s Health Institute	Western Institutional Review Board, IRB
GW Medical Faculty Associates	Western Institutional Review Board, IRB
Christiana Care Health System	Christiana Care, IRB
KO Clinical Research	Western Institutional Review Board, IRB
Virtus Research Consultants	Western Institutional Review Board, IRB
University of Maryland School of Medicine	University of Maryland-Baltimore, IRB
Wayne State University Physician Group	Western Institutional Review Board, IRB
Mercy Clinic	Western Institutional Review Board, IRB
University of Mississippi Medical Center	University of Mississippi Medical Center, IRB
Women’s Wellness Clinic	Western Institutional Review Board, IRB
Cooper University Hospital	Cooper Health System, IRB
Bosque Women’s Care	Western Institutional Review Board, IRB
Albert Einstein School of Medicine-Montefiore	Biomedical Research Alliance of New York IRB (BRANY IRB)
Drexel University College of Medicine	Western Institutional Review Board, IRB
Magee-Women’s Hospital	Western Institutional Review Board, IRB
PRISMA Health Upstate	Health Sciences South Carolina, IRB
Baylor Research Institute	Baylor Research Institute, IRB
Willowbend Health and Wellness	Western Institutional Review Board, IRB
Eastern Virginia Medical School	Eastern Virginia Medical School, IRB
Virginia Mason Medical Center	Western Institutional Review Board, IRB