This trial is active, not recruiting.

Condition menorrhagia
Treatment intrauterine ultrasound-guided radiofrequency ablation system
Sponsor Gynesonics
Start date October 2014
End date October 2017
Trial size 147 participants
Trial identifier NCT02228174, CL04502


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Sonography guided transcervical ablation of uterine fibroids with the Gynesonics Sonata system
intrauterine ultrasound-guided radiofrequency ablation system Gynesonics Sonata 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 to provide focal treatment of symptomatic fibroids responsible for heavy menstrual bleeding (HMB).

Primary Outcomes

Reduction in menstrual blood loss (MBL) as assessed by pictorial blood loss assessment chart (PBAC)
time frame: 12 months
Rate of surgical re-intervention for heavy menstrual bleeding due to treatment failure
time frame: 12 months

Secondary Outcomes

Safety - Adverse Device Effects
time frame: Each follow-up visit through 36 months
Reduction in total and perfused fibroid volumes
time frame: 12 months
Change in the symptom severity and quality of life subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) Questionnaire
time frame: 3, 6, 12, 24, and 36 months
Time to return to normal daily activity (days)
time frame: 30 days post-treatment
Overall subject treatment outcome using the Overall Treatment Effect Scale (OTE)
time frame: 6, 12, 24, and 36 months
Subject satisfaction
time frame: 6, 12, 24, and 36 months
Change in general health outcome
time frame: 3, 6, 12, 24, and 36 months
Subject pain and tolerance of procedure
time frame: Day 0 - Treatment
Mean length of stay
time frame: Day 0 - Treatment
Occurrence of Pregnancy and Pregnancy Outcome
time frame: All follow-up visits through 36 months
Change in Work Productivity and Activity Impairment
time frame: 3, 6, 12, 24, and 36 months

Eligibility Criteria

Female participants from 25 years up to 50 years old.

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

Additional Information

Official title Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gynesonics.