Sonography Guided Transcervical Ablation of Uterine Fibroids

Menorrhagia Clinical Trial

— SONATA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228174
• Other study ID #: CL04502
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2019

Study information

• Verified date: February 2020
• Source: Gynesonics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: November 2019
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia

Intervention

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).

Locations

Country	Name	City	State
Mexico	Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León	Monterrey	N.l.
United States	Basque Women's Care	Albuquerque	New Mexico
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Cooper University Hospital	Camden	New Jersey
United States	Advanced Women's Health Institute	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Carolina Women's Research and Wellness Center	Durham	North Carolina
United States	KO Clinical Research, LLC	Fort Lauderdale	Florida
United States	Baylor Research Institute	Fort Worth	Texas
United States	Willowbend Health and Wellness Associates	Frisco	Texas
United States	Greenville Health System	Greenville	South Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates	Naperville	Illinois
United States	Montefiore Medical Center	New York	New York
United States	Christiana Care Health Services, Inc.	Newark	Delaware
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Drexel University	Philadelphia	Pennsylvania
United States	Kelly H. Roy M.D. P.C.	Phoenix	Arizona
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	Mercy Clinic, Minimally Invasive Gynecology	Saint Louis	Missouri
United States	Virginia Mason Medical Center	Seattle	Washington
United States	George Washington University Hospital	Washington	District of Columbia
United States	Visions Clinical Research	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gynesonics

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Occurrence of Pregnancy	Subjects were asked about the possible occurrence of pregnancy.	All Follow-up Visits through 24 Months
Secondary	Pregnancy Outcome - Gestation Age	If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.	24 Months
Secondary	Pregnancy Outcome - Birth Weight	If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.	24 Months
Secondary	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