Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)
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| ClinicalTrials.gov Identifier: NCT02228174 |
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Recruitment Status :
Completed
First Posted : August 28, 2014
Results First Posted : February 19, 2019
Last Update Posted : February 11, 2020
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Sponsor:
Gynesonics
Information provided by (Responsible Party):
Gynesonics
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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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | October 2014 |
| Actual Primary Completion Date : | October 18, 2017 |
| Actual Study Completion Date : | November 2019 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Zaleplon
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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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| Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228174
Locations
Show 23 study locations
Sponsors and Collaborators
Gynesonics
Study Documents (Full-Text)
Documents provided by Gynesonics:
Documents provided by Gynesonics:
Study Protocol [PDF] February 14, 2018
Statistical Analysis Plan [PDF] September 2, 2014
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gynesonics |
| ClinicalTrials.gov Identifier: | NCT02228174 |
| Other Study ID Numbers: |
CL04502 |
| First Posted: | August 28, 2014 Key Record Dates |
| Results First Posted: | February 19, 2019 |
| Last Update Posted: | February 11, 2020 |
| Last Verified: | February 2020 |
Keywords provided by Gynesonics:
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Abnormal Uterine Bleeding associated with fibroids AUB-L Fibroids Heavy menstrual bleeding |
HMB Myoma Menorrhagia |
Additional relevant MeSH terms:
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Leiomyoma Myofibroma Menorrhagia Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage |
Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Hemorrhage Pathologic Processes Menstruation Disturbances |