Sonography Guided Transcervical Ablation of Uterine Fibroids

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

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.

Eligibility 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