Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)

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

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

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • N.l.
    • Monterrey, N.l., Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" de la Universidad Autonoma de Nuevo Leon
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Kelly H. Roy M.D. P.C.
  • Colorado
    • Denver, Colorado, United States, 80246
      • Advanced Women's Health Institute
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services, Inc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • KO Clinical Research, LLC
    • Wellington, Florida, United States, 33414
      • Visions Clinical Research
  • Illinois
    • Naperville, Illinois, United States, 60540
      • The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Clinic, Minimally Invasive Gynecology
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Basque Women's Care
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research and Wellness Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Baylor Research Institute
    • Frisco, Texas, United States, 75035
      • Willowbend Health and Wellness Associates
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)	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.	Baseline and 12 Months
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure	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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)	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.	Each Follow-up Visit through 24 Months
Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 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.	Baseline and 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	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.	Baseline and 12 Months
Time to Return to Normal Activity (RTNA) in Days	Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.	30 Day post-procedure
Overall Treatment Effect (OTE) at 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.	12 Months
Subject Satisfaction With Treatment at 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".	12 Months
Subject Willingness to Recommend Procedure at 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".	12 Months
Change in General Health State at 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.	Baseline and 12 Months
Subject Pain	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).	Immediately Post-procedure as well as Pre-discharge (Day 0)
Procedure Tolerance	Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".	Post-procedure (Day 0)
Mean Length of Stay	Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.	Day 0 - Day of Treatment
Occurrence of Pregnancy	Subjects were asked about the possible occurrence of pregnancy.	All Follow-up Visits through 24 Months
Pregnancy Outcome - Gestation Age	If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.	24 Months
Pregnancy Outcome - Birth Weight	If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.	24 Months
Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 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.	Baseline and 12 Months

Collaborators and Investigators

• Sponsor: Gynesonics

Publications and helpful links

General Publications

• Christoffel L, Bends R, Toub D, Schiermeier S, Pschadka G, Engelhardt M, Quinn S, Hartmann M, Habiba M, Felberbaum R, Brossner A, Schippert C, Romer T. Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System. J Gynecol Surg. 2022 Jun 1;38(3):207-213. doi: 10.1089/gyn.2021.0136. Epub 2022 Jun 13.
• Roy K, Robinson JK. Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years. J Gynecol Surg. 2022 Apr 1;38(2):143-147. doi: 10.1089/gyn.2021.0073. Epub 2022 Apr 1.
• Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.
• Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019 Jan;133(1):13-22. doi: 10.1097/AOG.0000000000003032.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 18, 2017
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Menorrhagia; Fibroids; HMB; Heavy menstrual bleeding; Myoma; Abnormal Uterine Bleeding associated with fibroids; AUB-L
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID Numbers: CL04502