Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)
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|ClinicalTrials.gov Identifier: NCT02228174|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia||Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||October 2014|
|Actual Primary Completion Date :||October 18, 2017|
|Estimated Study Completion Date :||October 2019|
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 Name: Gynesonics Sonata System
- Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) [ Time Frame: 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.
- Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure [ Time Frame: 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.
- Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious) [ Time Frame: 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.
- Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months [ Time Frame: 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.
- 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 Frame: 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.
- Time to Return to Normal Activity (RTNA) in Days [ Time Frame: 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.
- Overall Treatment Effect (OTE) at 12 Months [ Time Frame: 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.
- Subject Satisfaction With Treatment at 12 Months [ Time Frame: 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".
- Subject Willingness to Recommend Procedure at 12 Months [ Time Frame: 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".
- Change in General Health State at 12 Months [ Time Frame: 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.
- Subject Pain [ Time Frame: 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).
- Procedure Tolerance [ Time Frame: 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".
- Mean Length of Stay [ Time Frame: Day 0 - Day of Treatment ]Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.
- Occurrence of Pregnancy [ Time Frame: All Follow-up Visits through 24 Months ]Subjects were asked about the possible occurrence of pregnancy.
- Pregnancy Outcome - Gestation Age [ Time Frame: 24 Months ]If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.
- Pregnancy Outcome - Birth Weight [ Time Frame: 24 Months ]If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.
- Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228174
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