Sonography Guided Transcervical Ablation of Uterine Fibroids

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

Detailed Description
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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.

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

Conditions
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Menorrhagia

Intervention / Treatment
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* Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Treated with Sonata<br>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<br>* 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).<br>* Other names: Gynesonics Sonata System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abnormal Uterine Bleeding associated with fibroids, AUB-L, Fibroids, Heavy menstrual bleeding, HMB, Myoma, Menorrhagia