Trial Outcomes & Findings for Sonography Guided Transcervical Ablation of Uterine Fibroids (NCT NCT02228174)

Results Overview

The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score \< 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

147 participants

Primary outcome timeframe

Baseline and 12 Months

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Sonata Subjects treated with the Sonata System.
Overall Study STARTED	147
Overall Study Full Analysis Population	143
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sonography Guided Transcervical Ablation of Uterine Fibroids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sonata n=147 Participants Subjects treated with Sonata System.
Age, Continuous	42.9 years STANDARD_DEVIATION 4.28 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	43 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	49 Participants n=5 Participants
Race/Ethnicity, Customized White	60 Participants n=5 Participants
Region of Enrollment United States	125 Participants n=5 Participants
Region of Enrollment Mexico	22 Participants n=5 Participants
Pictorial Blood Loss Assessment Chart	300.6 Index STANDARD_DEVIATION 98.47 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Months

Population: Full Analysis Population (143) minus 1 subject who had surgical reintervention prior to 12 months and was excluded from analysis of bleeding reduction coprimary endpoint per the Statistical Analysis Plan.

The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score \< 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.

Outcome measures

Outcome measures
Measure	Subjects Treated With Sonata n=142 Participants Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)	64.8 percentage of participants Interval 56.3 to 72.6

PRIMARY outcome

Timeframe: 12 Months

Population: Full Analysis Population (143 subjects)

This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.

Outcome measures

Outcome measures
Measure	Subjects Treated With Sonata n=143 Participants Sonata is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with the Sonata system.
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure	99.3 Percentage of Participants Interval 95.1 to 99.9

SECONDARY outcome

Timeframe: Each Follow-up Visit through 24 Months

Population: Safety population - all subjects who recieved the Sonata treatment.

Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.