Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leiomyoma

Hemorrhage

Myofibroma

Uterine Hemorrhage

Menorrhagia

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

Anticonvulsants

Central Nervous System Depressants

All Drugs and Chemicals

Zaleplon

Intervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which 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 Sonata.

The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).

Intrauterine Ultrasound-Guided Radiofreq. Ablation System

The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.

Sonography Guided Transcervical Ablation of Uterine Fibroids

Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance

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.

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.

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.

The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.

The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.

Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.

The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.

Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: "very satisfied", "moderately satisfied", "somewhat satisfied", "somewhat dissatisfied", "moderately dissatisfied", and "very dissatisfied".

Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: "definitely yes", "probably yes", "probably no", and "definitely no".

Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.

Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).

Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".

Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.

Subjects were asked about the possible occurrence of pregnancy.

If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.

If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.

The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.

Gynesonics

All Adverse Events were evaluated by the Sponsor and reviewed by the study's Medical Advisory Board for relatedness and seriousness.

Sonata

Age, Continuous

Sex: Female, Male

Hispanic or Latino

Black or African American

White

Race/Ethnicity, Customized

United States

Mexico

Region of Enrollment

The PBAC is a validated assessment tool to estimate menstrual blood loss using icons representing various degrees of saturation of sanitary products. It is not a scale, but rather an index with values ≤100 to have been reported to represent eumenorrhea. In this study, women had to have heavy menstrual bleeding marked by a baseline PBAC of \>=150 and \<=500 to be eligible for study participation.

Pictorial Blood Loss Assessment Chart

Baseline Analysis Population was comprised of subjects who were treated and had any post-baseline data.

Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)

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.

Subjects Treated With Sonata

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.

Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)

Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure

Safety population - all subjects who recieved the Sonata treatment.

Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)

% Change in Total Mean Maximal Fibroid Volume

% Change in Perfused Mean Maximal Fibroid Volume

Full Analysis Population without imputation for this outcome measure.

Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months

Mean Change in SSS at 12 Months

Mean Change in HR-QoL at 12 Months

Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months

Time to Return to Normal Activity (RTNA) in Days

Overall Treatment Effect (OTE) at 12 Months

Subject Satisfaction With Treatment at 12 Months

Subject Willingness to Recommend Procedure at 12 Months

Change in General Health State at 12 Months

Overall Pain During Procedure

Overall Pain During Recovery

Safety Population - all treated subjects (147).

Subject Pain

Procedure Tolerance

Mean Length of Stay

Occurrence of Pregnancy

Pregnancy Outcome - Gestation Age

Pregnancy Outcome - Birth Weight

Change in mean Overall Work Impairment

Change in mean Activity Impairment

Subset of the Full Analysis Population who were employed and had paired responses at baseline and 12 months.

Spots Global Cancer Trial Database for Sonography Guided Transcervical Ablation of Uterine Fibroids

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