SONATA: Sonography Guided Transcervical Ablation of Uterine Fibroids

• Sponsor: Gynesonics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02228174
• Collaborator: (none)
• Enrollment: 147
• Locations: 23
• Arm: 1
• Duration (Months): 61
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Oct 18, 2017
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Subjects Treated with Sonata 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.

Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System; 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).; Other Names: Gynesonics Sonata System

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) [Baseline and 12 Months]

   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.

2. Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure [12 Months]

   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.

Secondary Outcome Measures

1. Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious) [Each Follow-up Visit through 24 Months]

   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.

2. Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months [Baseline and 12 Months]

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

3. 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 [Baseline and 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.

4. Time to Return to Normal Activity (RTNA) in Days [30 Day post-procedure]

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

5. Overall Treatment Effect (OTE) at 12 Months [12 Months]

   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.

6. Subject Satisfaction With Treatment at 12 Months [12 Months]

   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".

7. Subject Willingness to Recommend Procedure at 12 Months [12 Months]

   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".

8. Change in General Health State at 12 Months [Baseline and 12 Months]

   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.

9. Subject Pain [Immediately Post-procedure as well as Pre-discharge (Day 0)]

   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).

10. Procedure Tolerance [Post-procedure (Day 0)]

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

11. Mean Length of Stay [Day 0 - Day of Treatment]

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

12. Occurrence of Pregnancy [All Follow-up Visits through 24 Months]

    Subjects were asked about the possible occurrence of pregnancy.

13. Pregnancy Outcome - Gestation Age [24 Months]

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

14. Pregnancy Outcome - Birth Weight [24 Months]

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

15. Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months [Baseline and 12 Months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• premenopausal

• ≥ 25 and ≤ 50 years of age at time of enrollment

• experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months

• between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm

• at least one type 1, type 2, type 3, or type 2-5 fibroid.

• PBAC score ≥ 150 and ≤ 500

• consistent menstrual cycles

• not at material risk for pregnancy

• speaks and reads a language for which validated questionnaires are available

• willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements

Exclusion Criteria:

• pregnancy

• urgent need for surgery to treat fibroid symptoms

• desire for current or future childbearing

• presence of a tubal implant for sterilization

• postmenopausal by history

• presence of type 0 fibroids, unless < 1 cm in diameter

• presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size

• any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm

• bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7

• exclusive presence of fibroids that are insufficient to explain the severity of symptoms

• presence of clinically relevant fibroids that cannot be treated for technical reasons

• presence of an extrauterine pelvic mass that has not been diagnosed as benign

• IUD/IUS in situ within the washout period

• previous procedure for fibroids or heavy menstrual bleeding other than myomectomy

• myomectomy within 12 months

• any abnormality of the endometrial cavity that obstructs access of the handpiece

• contraindication to MRI

• total uterine volume > 1000 cc

• clinically significant adenomyosis

• confirmed or suspected diagnosis of clinically relevant endometriosis

• one or more clinically relevant fibroids that are significantly calcified.

• previous pelvic irradiation

• renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]

• evidence of disorders of hemostasis (AUB-C)

• abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines

• endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia

• confirmed abdominal / pelvic malignancy within the previous five years

• active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;

• use of a hormonally-relevant medication within the washout period

• use of an antifibrinolytic agent while undergoing any screening procedures

• current use of anticoagulant therapy

• chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain

• chronic uncontrolled moderate and severe hypertension

• hypoplastic or otherwise short uterus

• major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data

• any other reason for which the individual study subject is not appropriate or suitable for participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kelly H. Roy M.D. P.C.	Phoenix	Arizona	United States	85006
2	Advanced Women's Health Institute	Denver	Colorado	United States	80246
3	Christiana Care Health Services, Inc.	Newark	Delaware	United States	19718
4	George Washington University Hospital	Washington	District of Columbia	United States	20037
5	KO Clinical Research, LLC	Fort Lauderdale	Florida	United States	33316
6	Visions Clinical Research	Wellington	Florida	United States	33414
7	The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates	Naperville	Illinois	United States	60540
8	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
9	Wayne State University	Detroit	Michigan	United States	48201
10	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
11	Mercy Clinic, Minimally Invasive Gynecology	Saint Louis	Missouri	United States	63141
12	Cooper University Hospital	Camden	New Jersey	United States	08103
13	Basque Women's Care	Albuquerque	New Mexico	United States	87109
14	Montefiore Medical Center	New York	New York	United States	10467
15	Carolina Women's Research and Wellness Center	Durham	North Carolina	United States	27713
16	Drexel University	Philadelphia	Pennsylvania	United States	19104
17	Magee Women's Hospital	Pittsburgh	Pennsylvania	United States	15213
18	Greenville Health System	Greenville	South Carolina	United States	29605
19	Baylor Research Institute	Fort Worth	Texas	United States	76104
20	Willowbend Health and Wellness Associates	Frisco	Texas	United States	75035
21	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
22	Virginia Mason Medical Center	Seattle	Washington	United States	98101
23	Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León	Monterrey	N.l.	Mexico	64460

Sponsors and Collaborators

• Gynesonics

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 14, 2018
• Statistical Analysis Plan - Sep 2, 2014

More Information

Publications

None provided.

• Responsible Party: Gynesonics
• ClinicalTrials.gov Identifier: NCT02228174
• Other Study ID Numbers: CL04502
• First Posted: Aug 28, 2014
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Gynesonics: Abnormal Uterine Bleeding associated with fibroids; AUB-L; Fibroids; Heavy menstrual bleeding; HMB; Myoma; Menorrhagia
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Menorrhagia

Study Results

Participant Flow

Arm/Group Title	Sonata
Arm/Group Description	Subjects treated with the Sonata System.
Period Title: Overall Study
STARTED	147
Full Analysis Population	143
COMPLETED	142
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Sonata
Arm/Group Description	Subjects treated with Sonata System.
Overall Participants	147
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.9 (4.28)
Sex: Female, Male (Count of Participants)
Female	147 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	43 29.3%
Black or African American	49 33.3%
White	60 40.8%
Region of Enrollment (Count of Participants)
United States	125 85%
Mexico	22 15%
Pictorial Blood Loss Assessment Chart (Index) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Index]	300.6 (98.47)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
Description	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.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	142
Number (95% Confidence Interval) [percentage of participants]	64.8 44.1%

2. Primary Outcome

Title	Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population (143 subjects)

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	143
Number (95% Confidence Interval) [Percentage of Participants]	99.3 67.6%

3. Secondary Outcome

Title	Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
Description	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.
Time Frame	Each Follow-up Visit through 24 Months

Outcome Measure Data

Analysis Population Description

Safety population - all subjects who recieved the Sonata treatment.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	147
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months
Description	The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	129
% Change in Total Mean Maximal Fibroid Volume	-62.4 (32.81)
% Change in Perfused Mean Maximal Fibroid Volume	-63.9 (31.44)

5. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	135
Mean Change in SSS at 12 Months	-32.1 (21.03)
Mean Change in HR-QoL at 12 Months	43.7 (24.25)

6. Secondary Outcome

Title	Time to Return to Normal Activity (RTNA) in Days
Description	Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.
Time Frame	30 Day post-procedure

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	139
Mean (Standard Deviation) [Days]	2.2 (2.23)

7. Secondary Outcome

Title	Overall Treatment Effect (OTE) at 12 Months
Description	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.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	135
Fibroid Symptoms Improved	130 88.4%
Fibroid Symptoms Unchanged	4 2.7%
Fibroid Symptoms Worsened	1 0.7%

8. Secondary Outcome

Title	Subject Satisfaction With Treatment at 12 Months
Description	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".
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	135
Very Satisfied	95 64.6%
Modeately Satisfied	24 16.3%
Somewhat Satisfied	12 8.2%
Somewhat Dissatisfied	3 2%
Moderately Dissatisfied	1 0.7%
Very Dissatisfied	0 0%

9. Secondary Outcome

Title	Subject Willingness to Recommend Procedure at 12 Months
Description	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".
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	135
Definitely Yes	110 74.8%
Probably Yes	21 14.3%
Probably No	4 2.7%
Definitely No	0 0%

10. Secondary Outcome

Title	Change in General Health State at 12 Months
Description	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.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population without imputation for this outcome measure.

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	133
Mean (Standard Deviation) [units on a scale]	0.17 (0.223)

11. Secondary Outcome

Title	Subject Pain
Description	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).
Time Frame	Immediately Post-procedure as well as Pre-discharge (Day 0)

Outcome Measure Data

Analysis Population Description

Safety Population - all treated subjects (147).

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	147
Overall Pain During Procedure	0.24 (0.948)
Overall Pain During Recovery	2.63 (2.771)

12. Secondary Outcome

Title	Procedure Tolerance
Description	Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".
Time Frame	Post-procedure (Day 0)

Outcome Measure Data

Analysis Population Description

Safety Population - all treated subjects (147).

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	147
Very Tolerable	95 64.6%
Moderately Tolerable	45 30.6%
Minimally Tolerable	4 2.7%
Intolerable	3 2%

13. Secondary Outcome

Title	Mean Length of Stay
Description	Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.
Time Frame	Day 0 - Day of Treatment

Outcome Measure Data

Analysis Population Description

Safety Population - all treated subjects (147).

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	147
Mean (Standard Deviation) [Hours]	2.54 (1.243)

14. Secondary Outcome

Title	Occurrence of Pregnancy
Description	Subjects were asked about the possible occurrence of pregnancy.
Time Frame	All Follow-up Visits through 24 Months

Outcome Measure Data

Analysis Population Description

Full Analysis Population (143 subjects).

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	143
Count of Participants [Participants]	1 0.7%

15. Secondary Outcome

Title	Pregnancy Outcome - Gestation Age
Description	If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

1 subject with pregnancy

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	1
Number [weeks]	38.2

16. Secondary Outcome

Title	Pregnancy Outcome - Birth Weight
Description	If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

1 subject with pregnancy

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	1
Number [grams]	4005

17. Secondary Outcome

Title	Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months
Description	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.
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Subjects Treated With Sonata
Arm/Group Description	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.
Measure Participants	112
Change in mean Overall Work Impairment	-40.0 (34.22)
Change in mean Activity Impairment	-46.2 (31.21)

Adverse Events

Time Frame	12 Months
Adverse Event Reporting Description	All Adverse Events were evaluated by the Sponsor and reviewed by the study's Medical Advisory Board for relatedness and seriousness.
Arm/Group Title	Sonata
Arm/Group Description	Subjects treated with the Sonata System.
All Cause Mortality
	Sonata
	Affected / at Risk (%)	# Events
Total	0/147 (0%)
Serious Adverse Events
	Sonata
	Affected / at Risk (%)	# Events
Total	2/147 (1.4%)
Reproductive system and breast disorders
Vaginal Discharge with Overnight Hospital Stay	1/147 (0.7%)	1
Vascular disorders
Deep Vein Thrombus	1/147 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Sonata
	Affected / at Risk (%)	# Events
Total	60/147 (40.8%)
Infections and infestations
Genitourinary Infections	7/147 (4.8%)	8
Reproductive system and breast disorders
Cramping/Pain	11/147 (7.5%)	12
Fibroid Shedding	45/147 (30.6%)	53
Vaginal Discharge	9/147 (6.1%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.