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 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 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