Sonography Guided Transcervical Ablation of Uterine Fibroids

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 3months

• between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0cm 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, toparticipate 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 ofsymptoms

• 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 nationalguidelines

• 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 baselinepelvic 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 healthor subject's ability to adhere to the follow-up schedule or provide valid subjectself-assessment data

• any other reason for which the individual study subject is not appropriate or suitablefor participation